2021 SNMMI Highlights Lecture: Oncologyand Therapy, Part 1

Heiko Sch€oder, MD, MBA, Memorial Sloan Kettering Cancer Center, New York, NY

From the Newsline Editor: The Highlights Lecture, pre-sented at the closing session of each SNMMI Annual Meeting,was originated and presented for more than 30 years by HenryN. Wagner, Jr., MD. Beginning in 2010, the duties of summariz-ing selected significant presentations at the meeting weredivided annually among 4 distinguished nuclear and molecularmedicine subject matter experts. Each year Newsline publishesthese lectures and selected images. The 2021 Highlights Lec-tures were delivered on June 15 as part of the SNMMI VirtualAnnual Meeting. In this issue we feature the first part of the lec-ture by Heiko Sch€oder, MD, MBA, chief of the Molecular Imag-ing and Therapy Service at Memorial Sloan Kettering CancerCenter (New York, NY) and a professor of radiology at theWeill Medical College of Cornell University (New York, NY),who spoke on oncology and therapy highlights from the meet-ing. The second part of the lecture will appear in the Novemberissue of Newsline. Note that in the following presentation sum-mary, numerals in brackets represent abstract numbers as pub-lished in The Journal of Nuclear Medicine (2021;62[suppl 1]).

First I would like to thank the organizers for invitingme to give this year’s highlights lecture on oncologyand therapy. It is a pleasure to present these findings.

We will begin with a brief statistical characterization of theoncology-related abstracts presented at the 2021 SNMMIAnnual Meeting. The majority (51%) came from NorthAmerica, with a second large percentage of contributionsfrom Asia (41%), and others from Europe (6%), Africa(1%), and South America (1%). Among international coun-tries contributing, a large number of abstracts came fromChina (166), followed by Korea (61), Japan (57), India (34),Canada (34), and Australia (20). As in past years, the major-ity (80%) of these abstracts focused on diagnostics, withonly about 20% on therapeutic applications.

Among the highest rated abstracts in the clinical area,many were focused on fibroblast activation protein inhibitor(FAPI) and prostate-specific membrane antigen (PSMA)imaging in one form or another, and these will be discussedin detail in this lecture. In the area of basic research, no cleartopic emerged as dominant. A number of new probes werepresented at the meeting, and we will look at several ofthese. In the area of therapy, the large majority of abstractsfocused on prostate cancer and neuroendocrine tumors.

Clinical DiagnosticsFAPI

Many of us remember the 2019 SNMMI Image of theYear (Fig. 1) from multiple researchers at the University

Hospital Heidelberg (Germany), which showed FAPI uptakeacross a wide range of malignancies (1). In the intervening 2years, numerous case reports andsmall clinical studies have shownthe utility of FAPI-based imagingin diagnosis, staging, radiationtherapy planning, and changes inpatient management across a rangeof malignant diseases and sites,including (among others) the lung,pancreas, lower gastrointestinaltract, and head and neck and insarcoma and peritoneal carcinoma-tosis. Results from these and otherstudies, however, have also shownthat FAPI is not a cancer-specificagent. Uptake has been shown in a range of inflammatoryconditions, including thyroiditis, benign pancreatic lesions,pulmonary fibrosis, solitary fibrous tumor, and others, aswell as in the postmyocardial infarction setting.

As background, the tumor microenvironment includesblood vessels, extracellular matrix, and a number of differenttypes of cells, including cancer-associated fibroblasts(CAFs). CAFs are relevant in cancer progression, resistanceto therapy, and also in regulating the immune environment.They can be targeted by a number of therapies. FAP is atransmembrane glycoprotein and prognostic marker in can-cer expressed only on activated fibroblasts, including acti-vated CAFs. FAP can be targeted in a variety of ways,including by FAPIs, which we use for imaging. As noted, anumber of smaller studies have been published, and the fieldis ready to move on to larger and more quantitative analysesto study the role of FAPI in selected malignancies.

Kessler et al. from the University of Duisberg-Essen, theGerman Cancer Consortium (DKTK, Essen; DKFZ, Heidel-berg), and University Hospital Essen (all in Germany)reported on “68Ga-FAPI for sarcoma imaging: Data from theFAPI-PET prospective observational trial” [126]. The studyincluded 47 patients with bone and soft tissue sarcoma whounderwent clinical 68LGa-FAPI PET imaging, 46 of whomalso underwent 18F-FDG PET. The study’s primary endpointwas association of 68Ga-FAPI PET uptake intensity and his-topathologic FAP expression. Secondary endpoints weredetection rate, positive predictive value (PPV), interraterreproducibility, and change in management. The 68Ga-FAPItracer showed high sensitivity and PPV on a per patient andper region basis. In a comparison of detected rates, 68Ga-FAPI PET results were similar to those with 18F-FDG PET,although in some instances 18F-FDG provided additional

Heiko Sch€oder, MD

Newsline 9N

NEW

SLIN

E

information. It is possible that in the future, at least in somepatients, complete workups may require both radiotracers.The authors found that the 68Ga-FAPI tracer uptake corre-lated with immunohistochemistry (IHC)-assessed FAPexpression in sarcoma: the higher the FAP expression onIHC, the higher the SUV. Figure 2 is an example from 2patients, 1 with negative IHC FAP and no uptake on imag-ing, 1 with positive IHC FAP and high uptake on imaging.

Mona et al. from the University of California LosAngeles/University of California Los Angeles MedicalCenter reported on “Validation of FAPi PET biodistribu-tion by immunohistochemistry in patients with solid

cancers: A prospective exploratory imaging study”[1000]. This study included 15 patients and a variety oftumors and looked at similar correlations, using tissuemicroarrays to explore whether 68Ga-FAPi-46 PET imagebiodistribution accurately reflects FAP expression fromresected tumor and nontumor specimens. Figure 3 is aninteresting patient example, showing strong uptake in apancreatic tail ductal adenocarcinoma with the corre-sponding IHC stain. FAP IHC in representative histo-logic sections demonstrated variable negative-to-weakFAP expression in normal pancreatic parenchyma, exceptfor a subpopulation of cells in normal islets consistentlyshowing strong FAP expression. Again, we see a directrelationship between IHC in tissue and SUV on FAPIPET. The researchers concluded that this and associatedtranslational validation “pave the way for large-scale pro-spective trials on the use of 68Ga-FAPi-46 PET/CT as abiomarker and stratification tool for FAP-targetedtherapies.”

Other abstracts on FAPI imaging were presented at thismeeting, and time does not allow me to detail each of these,but several have already been published in major journals.Chen et al. from First Affiliated Hospital of Xiamen Univer-sity/Xiamen University (China) reported on the “Role of68Ga-FAPI PET/CT in the evaluation of peritoneal carcino-matosis and comparison with 18F-FDG PET/CT” [20] (2).This is a challenging indication in PET and PET/CT imag-ing. The retrospective study included 46 patients (16 withdiffuse-type peritoneal carcinomatosis, 27 with nodular-typeperitoneal carcinomatosis, and 3 true-negative patients). Theresearchers presented encouraging data indicating that FAPIuptake was higher than that of 18F-FDG, that FAPI PETallowed detection of smaller lesions, and that a particular

FIGURE 1. SNMMI 2019 Image of the Year:68Ga-FAPI PET/CT in patients reflecting 12 dif-ferent tumor entities. Ca 5 cancer; NSCLC 5

non–small cell lung cancer; CUP 5 carcinomaof unknown primary; CCC 5 cholangiocarci-noma; GEP-NET 5 gastroenteropancreaticneuroendocrine tumor. Image was created withcontributions from Clemens Kratochwil, PaulFlechsig, Thomas Lindner, Labidi Abderrahim,Annette Altmann, Walter Mier, Sebastian Ade-berg, Hendrik Rathke, Manuel Rohrich, HaukeWinter, Peter Plinkert, Frederik Marme, Mat-thias Lang, Hans Ulrich Kauczor, Dirk Jaeger,Juergen Debus, Uwe Haberkorn, and FrederikL. Giesel, each of whom was affiliated with Uni-versity Hospital Heidelberg (Germany).

FIGURE 2. 68Ga-FAPI for sarcoma imaging. Data from the FAPI-PETprospective observational trial [126]. Immunochemistry (IHC)-assessedFAP expression in sarcoma correlated well with 68Ga-FAPI tracer uptake.Top: IHC (left) and FAPI PET/CT (right) images in a patient with FAP– dis-ease. Bottom: corresponding images in a patient with FAP1 disease.

10N THE JOURNAL OF NUCLEAR MEDICINE � Vol. 62 � No. 10 � October 2021

NEW

SLIN

E

advantage for FAPI PET was evident in gastric and coloncancers.

Pang et al. from Xiamen University/First Affiliated Hos-pital of Xiamen (China) reported on “Comparisonof 68Ga-FAPI and 18F-FDG uptake in gastric, duodenal, andcolorectal cancers” [125] (3). They reported that 68Ga-FAPIPET/CT was superior to 18F-FDG PET/CT in detection ofprimary and metastatic lesions, with higher tracer uptake inmost primary and metastatic lesions.

Other related abstracts looked at nasopharyngeal cancer,where FAPI imaging provided additional advantages in eval-uating skull base invasion, suggesting that FAPI PET/MRmay become routine in future evaluations in this setting. Qinet al. from Union Hospital, Tongji Medical College, andHuazhong University of Science and Technology (Wuhan,China) reported on “A head-to-head comparison of 68Ga-DOTA-FAPI-04 and 18F-FDG PET/MR in patients withnasopharyngeal carcinoma: A prospective study” [124] (4).They found that 68Ga-FAPI outperformed 18F-FDG in delin-eating primary tumors and detecting distant metastases, par-ticularly in the evaluation of skull-base and intracranialinvasion, concluding that “68Ga-FAPI hybrid PET/MR hasthe potential to serve as a single-step staging modality” forpatients with nasopharyngeal cancer. Zhao et al. from theFirst Affiliated Hospital of Xiamen University (China)reported on the “Clinical utility of 68Ga-FAPI PET/CT forprimary staging and recurrence detection in nasopharyngealcarcinoma” [1086] (5) in a study with 45 participants. Theirdata also indicated higher uptake of 68Ga-FAPI than18F-FDG.

Prostate CancerProstate cancer remains a significant burden across the

globe, including the Americas, large portions of Africa and

Europe, and Australia. On May 12, a new Lancet Commis-sion was announced to study prostate cancer in greaterdetail, to create recommendations for prostate cancer diag-nosis and treatment, and to address disparities in prostatecancer management. The announcement noted that“genomic tools and imaging, particularly PSMA PET-CT,are likely to be increasingly important in treatment decisionsin the future” (6).

Two large and influential recent studies have focused onprostate cancer, 1 on 68Ga-PSMA-11 and the other on 18F-DCFPyL. Fendler from the University of California at LosAngeles and an international consortium of research centersreported in JAMA Oncology on an “Assessment of 68Ga-PSMA-11 PET accuracy in localizing recurrent prostate can-cer: A prospective single-arm clinical trial” (7). The studyincluded 635 men with biochemically recurrent prostate can-cer after treatment and identified high PPV, high detectionrate, and high interreader agreement for localization with68Ga-PSMA-11 PET. Morris et al. from Memorial SloanKettering Cancer Center (New York, NY) and an interna-tional consortium of research centers reported in ClinicalCancer Research on “Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrentprostate cancer: Results from the CONDOR phase III, multi-center study” (8). The study included 208 men with risingprostate-specific antigen (PSA) ≥0.2 ng/mL after prostatec-tomy or ≥2 ng/mL above nadir after radiotherapy. Of note,patients were included in the 68Ga-PSMA-11 study irrespec-tive of prior imaging findings, whereas in the 18F-DCFPyLstudy, the median PSA was lower and only patients withnegative or equivocal prior imaging were enrolled. Never-theless, we can identify common themes in their findings:higher overall detection rates (75% for 68Ga-PSMA-11;59%–66% with 18F-DCFPyL) correlated with increasingPSA levels and very respectable numbers in terms of PPVand sensitivity (sensitivity here referring to cases with histo-logic verification). Reader agreement results were also goodwith both tracers.

Rowe from Johns Hopkins Medicine (Baltimore, MD)and the CONDOR consortium provided additional datafrom their study at this meeting in “A phase 3 study of18F-DCFPyL PET/CT in patients with biochemicallyrecurrent prostate cancer (CONDOR): An analysis of dis-ease detection rate and PPV by anatomic region” [123].They found that 18F-DCFPyL PET/CT detected and local-ized metastatic lesions with high PPV regardless of ana-tomic region (prostate/prostate bed, pelvic lymph nodes, orextrapelvic regions, including lymph nodes, bone, and vis-cera/soft tissue) (Fig. 4). Higher PPVs were observed inextrapelvic lymph nodes and bone compared to viscera/soft tissue. This is, of course, important, because an imag-ing agent may not be very useful if it addresses diseaseonly in the pelvis but not outside (or vice versa). I shouldpoint out that the number of visceral lesions in this studywas quite small, so related data probably should not beoverinterpreted.

FIGURE 3. Validation of FAPi PET biodistribution by immunohistochem-istry (IHC) in patients with solid cancers. Example: 65-year-old man withpancreatic ductal adenocarcinoma (yellow arrows: pancreatic tail ductaladenocarcinoma lesion; white arrows: resected normal pancreas region).(A) Whole-body PET; (B) transaxial CT; (C) transaxial PET/CT (SUVmax

15.69); (D) transaxial PET (SUVmean 12.51). (E) FAP IHC on representativehistologic sections demonstrated variable negative-to-weak FAP expres-sion in normal pancreatic parenchyma with a subpopulation of cells in nor-mal islets consistently showing strong FAP expression; and (F) moderate-to-strong FAP expression was noted for tumor tissue.

Newsline 11N

NEW

SLIN

E

Other abstracts were presented on these and otherPSMA compounds. Although I cannot detail each one, Iwant to highlight 4 as illustrative of current research andfindings. Lin et al. from the University of California at SanFrancisco reported on “The increased prevalence of low andheterogeneous PSMA uptake in the setting of metastaticcastration-resistant prostate cancer” [1349]. In thisretrospective study, low PSMA uptake (≥1 lesion withno-to-low PSMA uptake) was seen on .50% of scans, andheterogeneous uptake (defined as both low and high PSMAuptake lesions on the same scan) was seen on .40% ofscans. The authors concluded that this high degree of hetero-geneity within patients and in low PSMA-expressing tumorsmay complicate treatment, particularly with PSMA-targetedradioligand therapy.

Maliha et al. from McGill University Health Center, theUniversity of Montreal, and the Jewish General Hospital (allin Montreal, Canada) reported on “Physiological DCFPyLPSMA-targeted tracer uptake in the epididymis head newlyappreciated on digital PET/CT” [1321]. This was an interest-ing incidental finding, and the authors noted that it is bothcommon and more frequent in patients with higher serumtestosterone levels. They emphasized that this physiologicfinding should not be misinterpreted as pathologic.

Lindenberg et al. from the National Cancer Institute(NCI), the University of California San Francisco, Johns Hop-kins University School of Medicine (Baltimore, MD), YaleUniversity (New Haven, CT), and Novartis Pharmaceuticals(East Hanover, NJ; Turin, Italy; and Geneva, Switzerland)reported on “Safety and tolerability of 68Ga-PSMA-R2 as animaging agent in patients with biochemical recurrence or met-astatic prostate cancer” [1319]. In this safety and tolerabilitystudy, the PSMA agent was well tolerated with no significantadverse events. The authors concluded that the lesion detect-ability and low radiation dose absorbed by salivary and lacri-mal glands compared with other PSMA PET agents arepromising for future therapeutic applications.

Miksch et al. from University Hospital Ulm, the Techni-cal University Munich (Garching), and the German ArmedForces Hospital Ulm (all in Germany) reported that “Novel18F-siPSMA-14 shows favorable kinetics and high interob-server agreement in staging of prostate cancer patients”[1328]. The study analyzed biodistribution, detection rates,and interobserver agreement in 134 patients with either pri-mary prostate cancer or recurrent disease. On a 5-point grad-ing system, good agreement was noted (94% in primary and86% in recurrent disease). As in previous abstracts, higherdetection rates were found with higher PSA levels. Noforced diuresis was used in the study. Target-to-nontargetratios were notably high in PET/CT-positive tumors (9.3 inprostate, 11.6 in lymphatic, 14.3 in bone, and 14.6 in vis-ceral lesions), enabling excellent contrast imaging. This con-trast is evident in Figure 5 in a patient assessed for primarydisease after chemotherapy. On the left, excreted activity in

FIGURE 4. Left: Representative imaging from the 68Ga-PSMA-11 PET/CT trial from UCLA and an international consortium. Right: Representativeimaging from the CONDOR phase III 18F-DCFPyL PET/CT trial. Despitedifference in enrollment criteria and procedures, common findingsincluded higher overall detection rates that correlated with increasingprostate-specific antigen levels, good positive-predictive values, andimproved sensitivity. Reader agreement results were also high withboth tracers.

FIGURE 5. 18F-siPSMA-14 in staging prostate cancer patients. Imagesacquired in a 64-year-old man with progressive disease after chemother-apy (prostate-specific antigen 5 100 ng/mL). Left: excreted activity onPET in the urinary bladder obscures the primary tumor. Right: contrast ishigh on 18F-siPSMA-14 PET/CT for bone (top), lymph node metastases(middle), and (although some excreted activity is seen in the bladder)much higher uptake is apparent in the primary tumor (bottom).

12N THE JOURNAL OF NUCLEAR MEDICINE � Vol. 62 � No. 10 � October 2021

NEW

SLIN

E

the urinary bladder obscures the primary tumor; on the right,contrast is high for bone and lymph node metastases and,although some excreted activity is seen in the bladder, muchhigher uptake is apparent in the tumor. This tracer is espe-cially promising, then, for detecting locoregional recurrence.

Other ApplicationsNaghavi-Behzad et al. from the University of Southern

Demark (Odense), Odense University Hospital (Odense,Denmark), the Basel Academy for Quality and Research inMedicine (Switzerland), and the Technical University ofMunich (Germany) reported on “Response monitoring inmetastatic breast cancer: A comparison of survival timesbetween FDG PET/CT and contrast-enhanced CT” [129].This study is relevant to a challenge with which many of usdeal on a day-to-day basis in our practices: arguing withinsurance companies about whether a scan should be preap-proved for reimbursement. Patients in the study underwentconventional imaging with contrast-enhanced CT (144patients), FDG PET/CT (83 patients), or both (72 patients)as part of response monitoring to treatment. Their resultsindicated that overall, 5-year survival rates for patients withmetastatic breast cancer were significantly higher with PET/CT alone (41.9%) or in combination with contrast-enhanced-CT (43.3%) than with contrast-enhanced CT alone(15.8%). Why would patients with PET imaging have bettersurvival? The answer, of course, is that the improved sur-vival is not related to the modality per se but to the fact thatPET enables earlier detection of recurrence and more timelyand appropriate management decisions. This study is clearevidence of the utility of PET/CT in response assessment inpatients with breast cancer and provides the kind of quantita-tive data that may prove persuasive to third-party payers.

Clinical TherapiesGreat advances are being reported in clinical therapies in

our field, highlighted this year by 2 recent clinical trials inpatients with advanced prostate cancer. Results from theVISION trial were reviewed on June 6 at the American Soci-ety of Clinical Oncology (ASCO) meeting by Michael Mor-ris, MD, from Memorial Sloan Kettering Cancer Center(New York, NY). The study has primary endpoints compar-ing radiographic progression-free survival and overall sur-vival in patients with progressive PSMA-positive metastaticcastrate-resistant prostate cancer who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care ver-sus patients treated with best supportive/best standard of carealone. The study enrolled patients who had positive PSMAsignals on PET imaging and who had previously receivedtaxane therapy and novel androgen axis therapy and werenow deemed eligible only for best supportive care. It isimportant to point out that no PSMA-only arm was includedin the study. Both the ASCO presentation and recently pub-lished results show that the treatment arm in the VISIONtrial had better overall survival and better radiographic

progression-free survival with improved quality of life. Welook forward to more analyses and results from this trial.

The next trial was the TheraP trial, which had someimportant differences from the VISION trial. Hofman et al.from the Peter MacCallum Cancer Centre/University ofMelbourne, St. Vincent’s Hospital and Garvan Institute ofMedical Research (Sydney), Royal Brisbane and Women’sHospital (Brisbane), Royal Adelaide Hospital, Sir CharlesGairdner Hospital Western Australia (Nedlands), CalvaryMater Newcastle, Austin Health Melbourne, Monash Health(Melbourne), and Fiona Stanley Hospital (Murdoch; all inAustralia) reported at the SNMMI meeting on “177Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer: A randomized, open-label, phase 2trial (TheraP)” [1703] (9). Patients with progressive diseaseafter docetaxel therapy at 11 sites in Australia were firstimaged with both 68Ga-PSMA and 18F-FDG PET/CT. Onlythose with positive PSMA uptake that was concordant withFDG uptake were included in the trial. A resulting total of200 men were then randomized to 177Lu-PSMA-617 or cab-azitaxel. Figure 6 includes examples from the study illustrat-ing the concordant and discordant imaging findings used inpatient selection. The patient on the top left, for example,showed low PSMA uptake and high FDG uptake, and sowas ineligible for the trial. Next is a patient who had positiveuptake of both tracers but with additional metastases seenonly on FDG, a discordance that made the patient ineligible.This is in contrast to the eligible patients (bottom row) withconcordant uptake on both scans and with PSMA-dominantfindings. Imaging, then, was used to maximize the inclusionof patients most likely to benefit from 177Lu-PSMA-617treatment. 177Lu-PSMA-617 led to significantly greater PSAreductions (66% experienced ≥50% reduction in PSA frombaseline, compared with only 37% with cabazitaxel), higherobjective response rates (49% vs. 24%; RECIST 1.1), longerprogression-free survival at 1 year (19% vs. 3%), and signif-icant improvements in several patient-reported outcomedomains. Of note, the investigators also reported on compar-ative side effects. Patients in the 177Lu-PSMA-617 armexperienced fewer grade 3 or 4 adverse events (53% vs33%) and overall reported fewer side effects. We look for-ward to seeing immediate benefits with this life-saving andquality-of-life-improving treatment for our patients withprostate cancer. [Author’s note: On the same day this lecturewas given, the U.S. Food and Drug Administrationannounced that it had granted Breakthrough Therapy desig-nation for 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer.]

In the context of radionuclide therapies, dosimetry isvery important for both normal organs/tissues and targetlesions. The process, however, can be quite time-consuming, requiring multiple scans on several subsequentdays. Investigators across the globe are looking for solu-tions, particularly at whether advanced computationalmodeling can be used to derive dosimetry data with reason-able accuracy from a single time-point scan. Chicheportiche

Newsline 13N

NEW

SLIN

E

et al. from Hadassah–Hebrew University Medical Center(Jerusalem, Israel), Hebrew University of Jerusalem (Israel),and University College London/UCL Hospitals NHS Trust(London, UK) asked “Can absorbed radiation doses byorgans and tumors after peptide-receptor radionuclide ther-apy (PRRT) be estimated from a single SPECT/CT study?”[18]. The aim was to assess the feasibility of using a singlequantitative SPECT/CT study after each PRRT cycle com-bined with a trained multiple linear regression model forabsorbed dose calculation. The researchers found that in

a test set with data from 40 patients, their dosimetry calcula-tion method was in good agreement with the standardmulti-timepoint imaging protocol, with no associatedchanges in management decisions (Fig. 7). The conclusionwas that if this can be confirmed in a larger series it mayvery well be possible to perform a single scan to deriveaccurate dosimetry for PRRT and potentially other applica-tions. This would result not only in simplification of thedosimetry process but also improved patient comfort andreduced scanner and staff time.

Interest continues in using nonimaging tools to improveour ability to predict and measure response to therapies.Blood-based molecular gene signatures are being incorpo-rated into noninvasive tools to provide clinical guidance andfacilitate management during PRRT, which may prove espe-cially useful, because radiographic pseudoprogression is aknown confounding factor during PRRT. Bodei et al. fromMemorial Sloan Kettering Cancer Center (New York, NY),Wren Laboratories (Branford, CT), and Yale UniversitySchool of Medicine (New Haven, CT) reported on “Blood-based genomic assessment of the clinical efficacy and toxic-ity of PRRT” [78]. These researchers used 3 independentblood-based gene expression assays: a 51-marker gene NET-est (liquid biopsy) to monitor therapeutic efficacy, PRRTPredictor Quotient (a molecular marker used to predictPRRT responsiveness), and a 16-gene radiation toxicityassay to assess PRRT-related toxicity. In a cohort of 177Lu-PRRT–treated patients with gastroenteropancreatic neuroen-docrine and lung tumors, these assays were explored fortheir suitability in predicting treatment response, monitoringresponse, or use as safety biomarkers to monitor renal func-tion and predict toxicity. Each of the assays showed quitepositive results. This is a work in progress, and series withlarger numbers are forthcoming. If validated, this will be ahelpful tool in predicting and monitoring patient response toDOTATATE therapy in neuroendocrine tumors.

Morgan et al. from the University of Colorado MedicalCenter (Aurora) reported on “Utilization and cost of

FIGURE 6. 177Lu-PSMA-617 vs cabazitaxel in metastatic castration-resistant prostate cancer: TheraP trial. Patients with progressive diseaseafter docetaxel therapy were first imaged with both 68Ga-PSMA and18F-FDG PET/CT, and only those with positive PSMA uptake that wasconcordant with FDG uptake were included in the trial. Images show PET(top) and PET/CT (bottom row) illustrating concordant and discordant find-ings used in patient selection. Top box: A patient with low PSMA uptakeand high FDG uptake (left, ineligible for the trial); patient with positiveuptake of both tracers but additional metastases seen only on FDG (right,discordant, ineligible). Bottom row: patient with concordant uptake onboth scans (left, eligible); and patient with PSMA-dominant findings (right,eligible). Imaging was used to maximize inclusion of patients most likely tobenefit from 177Lu-PSMA-617 treatment.

FIGURE 7. Single-timepoint imag-ing for dosimetry in peptide-receptorradionuclide therapy (PRRT).Researchers used a trained modelfor dose calculation with a singlequantitative SPECT/CT study aftereach PRRT cycle for absorbed dosecalculation (example image shown).The method was in good agreementwith the standard multi-timepointimaging protocol, with no associatedchanges in management decisions.

14N THE JOURNAL OF NUCLEAR MEDICINE � Vol. 62 � No. 10 � October 2021

NEW

SLIN

E

223Ra-dichloride (Xofigo) for treatment of metastaticcastration-resistant prostate cancer in the U.S. Medicarepopulation” [1309]. This is an interesting study because theauthors looked not only at utilization patterns from 2015 to2017 (a period during which they noted a significantincrease) but at which physicians/disciplines were actuallyadministering the therapy. More than 57% of treatmentswere administered by radiation oncologists. This seems tobe a clear call to action for the nuclear medicine community.Two years ago, Czernin et al. published an article in TheJournal of Nuclear Medicine highlighting potential weak-nesses and challenges for nuclear medicine, including insuf-ficient training, loss of ownership, and lack of desire toperform theranostic applications or to perform therapy (10).There is a reason that the word “medicine” is in the name ofour discipline—we encompass both diagnosis and therapy.We can continue to administer therapy and expand the rangeof these activities only if we as a community have the col-lective desire to do so, as well as the skills, infrastructure,and training programs. This is an appeal to all nuclear medi-cine professionals to work together to remain as owners ofour therapy and theranostic applications.

Part 2 of the 2021 Oncology and Therapy Highlights,in the November issue of Newsline, will focus on newtargets for radionuclide therapy and other novel therapy

approaches, as well as new techniques and methods for dataanalysis.

REFERENCES

1. SNMMI. SNMMI Annual Meeting spotlights new innovations and expanding hori-zons. J Nucl Med. 2019;60[8]:2N.

2. Zhao L, Pang Y, Luo Z, et al. Role of [68Ga]Ga-DOTA-FAPI-04 PET/CT in theevaluation of peritoneal carcinomatosis and comparison with [18F]-FDG PET/CT.Eur J Nucl Med Mol Imaging. 20201;48(6):1944–1955.

3. Pang Y, Zhao L, Luo Z, et al. Comparison of 68Ga-FAPI and 18F-FDG uptake ingastric, duodenal, and colorectal cancers. Radiology. 2021;298(2):393–402.

4. Qin C, Liu F, Huang J, et al. A head-to-head comparison of 68Ga-DOTA-FAPI-04and 18F-FDG PET/MR in patients with nasopharyngeal carcinoma: A prospectivestudy. Eur J Nucl Med Mol Imaging. 2021 Feb 20. Online ahead of print.

5. Zhao L, Pang Y, Zheng H, et al. Clinical utility of [68Ga]-labeled activation proteininhibitor (FAPI) positron emission tomography/computed tomography for primarystaging and recurrence detection in nasopharyngeal carcinoma. Eur J Nucl MedMol Imaging. 2021 Apr 1. Online ahead of print.

6. James N, Lee N, Horton R. Announcing the Lancet Commission on Prostate Can-cer. Lancet. 2021; 397(10288):1865–1966.

7. Fendler WP, Calais J, Eiber M, et al. Assessment of 68Ga-PSMA-11 PET accuracyin localizing recurrent prostate cancer: A prospective single-arm clinical trial.JAMA Oncol. 2019;5[6]:856–863.

8. Morris MJ, Rowe SP, Gorin, et al. Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: Results from the CON-DOR phase III, multicenter study. Clin Cancer Res. 2021;27(13):3674–3682.

9. Hofman MS, Emmett L, Sandhu S, et al. [177Lu]Lu-PSMA-617 versus cabazitaxelin patients with metastatic castration-resistant prostate cancer (TheraP): A ran-domised, open-label, phase 2 trial. Lancet. 2021;397(10276):797–804.

10. Czernin J, Sonni I, Rasmaria A, Calais J. The future of nuclear medicine as anindependent specialty. J Nucl Med. 2019;60(suppl 2):3S–12S.

SNMMI and ACGME Equity Matters Initiative

SNMMI announced on August 4 its partnership withthe Accreditation Council for Graduate MedicalEducation (ACGME) in ACGME Equity Matters, a

new initiative that introduces a framework for continuouslearning and process improvement in diversity, equity,inclusion, and antiracism practices. The initiative aims todrive change within graduate medical education byincreasing physician workforce diversity and building safeand inclusive learning environments, while promotinghealth equity by addressing racial disparities in health careand overall population health.

The ACGME Equity Matters framework includes 2 keycomponents: (1) educational resources that will be availableto all involved in GME; and (2) collaborative LearningCommunities drawn from national stakeholder groups madeup of GME Sponsoring Institutions and programs, includingfaculty members and individual residents/fellows, as well asspecialty societies and other health care partners. The Councilof Medical Specialty Societies (CMSS), of which SNMMI isa member, and the Organization of Program Director Associa-tions (OPDA) launched their participation in the program with

the convening of 2 Learning Communities that will initiate an18-mo engagement cycle. This partnership will support diver-sity, equity, inclusion, and antiracist practices and policiesacross the full continuum from physician training to physi-cians in practice. Core teams from CMSS and OPDA mem-bers will include an elected leader to champion the initiativeand senior executive leaders who will be accountable forimplementing policy and practice changes.

The ACGME program will offer a phased curriculum toenable participants to move through progressively more com-plex concepts within 4 domains: acknowledgment, acceptanceand accountability, action, and assessment and adaptation.Also included will be tools and skills training to drive imple-mentation of innovative interventions, practices, policies, anddata strategies. Forty-two organizations, including 31 CMSSMember Specialty Societies and 11 PDAs, will be participatingin the inaugural 18-mo cohort of the learning communities.More information is available at: https://acgme.org/What-We-Do/Diversity-Equity-and-Inclusion/ACGME-Equity-Matters/.

SNMMIACGME

Newsline 15N

NEW

SLIN

E

I N M E M O R I A M

Amnon (Amy) Piepsz, MD (1938–2021)

Amnon Piepsz was born in 1938 inAntwerp (Belgium) and died inBrussels (Belgium) on July 26,

2021, after a 2-year illness. He completedhis studies in pediatrics in 1967 at the VrijeUniversiteit Brussel (VUB) and becameinterested in nuclear medicine methodolo-gies very early in his career, attracted byits physiologic and noninvasive approach.He completed his studies in nuclear medi-cine in 1969 at the VUB and advancedthere rapidly to become a full professor ofboth pediatrics and nuclear medicine. HisPhD thesis in 1988 was on a “Methodologyof separate clearance measurement bymeans of 99mTc-DTPA and the gamma camera.”Dr. Piepsz radiated enthusiasm for nuclear medicine

throughout his career and was a major contributor to the“Consensus report on quality control of quantitativemeasure-ments of renal function obtained from the renogram” (SeminNucl Med. 1999; 29:146–159), published by the InternationalScientific Committee of Radionuclides in Nephrourology(ISCORN). His main areas of interests are reflected in morethan 250 peer-reviewed publications and were directedtoward development of clearance methodologies in childrenand adults and both experimental and clinical studies relatedto pediatric nephrourologic problems.He worked as a pediatrician in a general outpatient clinic

with special interests in urinary tract infections, themother–child relationship, and psychosomatic diseases.Most of his career was spent at the Centre Hospitalier Univer-sitaire Saint-Pierre (Brussels, Belgium) and in the AcademicHospital of the VUB. After his official retirement, he contin-ued towork as a volunteer at GhentUniversityHospital,wherehe pursued his research and the education of trainees.Dr. Piepsz became a genuine world citizen, giving lectures

and courses in such diverse locales as Bombay, Cape Town,Djakarta, and Paris. He also lectured under the sponsorship ofthe International Atomic Energy Agency, the EuropeanSchool of Nuclear Medicine (European Association ofNuclear Medicine [EANM]), and the Universit�e Paris-Sud.In addition, he was active in supporting the development ofnuclear medicine in many less developed countries and inSouth America, especially Chile. He was fluent in multiple

languages, including French, Flemish, Ger-man, English, Italian, and Spanish and lovedto visit cities to become familiar with theirinhabitants and cultures.He was an active member of the Societies

of Nuclear Medicine and of Pediatrics ofBelgium and of the EANM. He was thebeloved chair of the Paediatric Task Groupof the EANM, on which he served formore than 20 years. He served as an editorof the European Journal of Nuclear Medi-cine and a scientific reviewer for The Jour-nal of Nuclear Medicine and many otherjournals. He also coedited Functional Imag-ing in Nephro-Urology (London, UK: Tay-

lor and Francis; 2006) under the auspices of ISCORN.His life outside of medicine was rich. As a 15-year-old, he

earned First Prize in piano at the Conservatoire Royal deMusique of Brussels. An extraordinary pianist, he played awide range of music with expertise and feeling. He gave pri-vate concerts in duet with a violinist and also sang bass in theEuropean Union Choir (of which he was president from1999–2004). Hewas a lover of art and liked to swim, play ten-nis, and hike in the mountains with colleagues.His nickname, Amy, perfectly characterized his generous

personality (“ami” being French for “friend”). He had quali-ties rarely seen in a single person andwas an inspirational fig-ure for all in nuclear medicine. He was especially attentive totrainees and eager to share his scientific knowledge and clin-ical hands-on techniques. He was far more than an imagingspecialist; he was an attentive clinician and sympathetic phy-sicianwhowas devoted to his pediatric patients, their parents,members of his department, and his collaborators. He alwaysshared his enthusiasm and joy with others. We will miss himand remember him fondly.

Alain Prigent, MD, PhDParis, France

M. Donald Blaufox, MD, PhDNew York, NY

Andrew Taylor, MDAtlanta, GA

Naomi Alazraki, MDAtlanta, GA

16N THE JOURNAL OF NUCLEAR MEDICINE � Vol. 62 � No. 10 � October 2021

NEW

SLIN

E

S N M M I L E A D E R S H I P U P D A T E

State of the Society: SNMMI Thrives DespiteCOVID-19 ChallengesVirginia Pappas, CAE, SNMMI CEO

Over the past year, SNMMI has navigated the mostdifficult operating environment we have experiencedin our history. Throughout the year, SNMMI’s board

of directors and management team collaborated closely toenable the organization to deliver services to our membersand meet the health and safety needs of our employees, thenmove above and beyond to conceive and implement new,exciting programs and ideas.

From the start of the pandemic, SNMMI took precau-tions to ensure the safety of members and staff, changingmeetings to virtual formats and creating a new, effectivework environment for staff and society operations. WithSNMMI’s already extensive experience in the virtual envi-ronment, these functions not only proved engaging andeffective but also expanded our presence in the nuclear med-icine space worldwide.

At the same time, the society worked closely with feder-al organizations and other groups on COVID-related issues,including vaccination priority for members and the availabil-ity of essential isotopes and amino acid solution. SNMMIalso created an online COVID-19 Resource Center to ensurethat members had the news, information, and advice theyneeded to support them in their practice.

Despite the challenges of the pandemic, SNMMI hasadvanced not only our existing projects but also a widerange of new initiatives. To promote advances in radiophar-maceutical therapy, a Radiopharmaceutical Therapy Centersof Excellence program and a Radiopharmaceutical TherapyRegistry have been created. A therapy toolkit for sites begin-ning implementation has been developed, as well as practiceresources, education, and information regarding dosimetry.New research fellowships, awards, and a technologist ther-apy badging program are now available or in progress.Much of this information can be found on the new RPTwebsite portal at www.snmmi.org/therapy.

SNMMI has launched a new initiative to increase aware-ness of nuclear medicine among referring physicians and thegeneral public, utilizing broad-based consumer media out-reach. The society has also promoted cutting-edge researchvia The Journal of Nuclear Medicine, which dramaticallyincreased its impact and influence among 133 medical jour-nals in the medical imaging category.

In the health policy and regulatory affairs area, the FINDAct of 2021 was introduced in both the House of

Representatives and the Senate. If passed, this legislationwould significantly expand patient access to a wide rangeof diagnostic radiopharmaceuticals that can better detectconditions such as heart disease, Alzheimer and Parkin-son disease, breast and prostate cancer, and neuroendo-crine tumors. This legislation would also help providersbetter manage costs while delivering more targeted andcost-efficient care.

Years of work from SNMMI and its partners also paidoff this summer as the Centers for Medicare and MedicaidServices (CMS) and Humana allowed coverage for nonon-cologic PET imaging. In addition, with the retirement of theNational Coverage Determination for 18F-FDG PET infec-tion and inflammation, coding barriers have been removedand coverage determinations are now made by local Medi-care Administrative Contractors. CMS is also consideringnew coverage for beta-amyloid imaging, which is supportedby SNMMI.

Understanding that artificial intelligence will greatlyimpact the future of medicine, SNMMI has created severalrelated initiatives. An Artificial Intelligence Taskforce,formed earlier this year, launched a challenge in conjunctionwith the Michael J. Fox Foundation to collect clinical datafrom DaTScan images. The task force has also been draftingmanuscripts for submission to JNM and planning for anArtificial Intelligence Summit to be held in early 2022.

During the pandemic, fantastic progress has been madein the development of new agents and therapies, setting upthe profession for increasing growth. Looking forward, wehope to hold events in-person to support this growth, includ-ing the Therapeutics Conference, November 11–14, 2021, inNew Orleans, LA, and the Mid-Winter Meeting, January28–31, 2022, in Orlando, FL.

I am proud to share with you that the decisions wemade have put SNMMI on track to end fiscal year 2021with very healthy positions of operating cash and invest-ments. We are extremely grateful for our leadership,members, volunteers, corporate partners, and employeeswho have come together during this challenging time toenable SNMMI to continue to promote the value ofnuclear medicine, molecular imaging, and radionuclidetherapy. The innovative programs and services developedwere extraordinarily successful and have allowed thesociety to remain healthy and strong.

Newsline 17N

NEW

SLIN

E

N E W S B R I E F S

HHS Inspector General toReview FDA AcceleratedApproval Pathway

The Office of Inspector General(OIG) of the U.S. Health and HumanServices announced on August 4 that itwould launch a review process of therecent U.S. Food and Drug Adminis-tration (FDA) approval of Aduhelm(aducanumab) to treat patients withAlzheimer disease under the acceler-ated approval pathway. The pathwayallows the FDA to approve drugs thattreat serious conditions and that fill anunmet medical need based on a surro-gate endpoint. According to an OIGpress release, this approval “raisedconcerns due to alleged scientific dis-putes within the FDA, the advisorycommittee’s vote against approval,allegations of an inappropriately closerelationship between the FDA and theindustry, and the FDA’s use ofthe accelerated approval pathway.” Inthe review, the OIG will assess howthe FDA implements the acceleratedapproval pathway and manages inter-actions with outside parties, as well asother aspects of the process, such asdeciding how scientific disputes areresolved. FDA’s relevant policies andprocedures, along with compliance,will be included in the review, basedon a sample of drugs approved usingthe accelerated pathway. The OIG willnot assess the scientific appropriate-ness of the FDA approval of any drugsunder review. This work may result inmultiple reports, expected to be issuedin 2023.

Office of Inspector GeneralU.S. Health and Human Services

FIND Bills in House and SenateOn July 16, Congresspersons Scott

Peters (D-CA), Bobby Rush (D-IL),Neal Dunn (R-FL), and Greg Murphy(R-NC) introduced the FacilitatingInnovative Nuclear Diagnostics (FIND)Act of 2021 (HR 4479), intended to sig-nificantly expand patient access toadvanced nuclear diagnostic imagingtechnologies. The bill (previously HR

3772) targets creation of a legislativefix to the Center for Medicare and Med-icaid Services (CMS) bundling of diag-nostic radiopharmaceuticals in thehospital outpatient space after a 3-yearpass-through period postapproval by theU.S. Food and Drug Administration.

SNMMI and its coalition partners,the Medical Imaging & TechnologyAlliance and the Council on Radionu-clides and Radiopharmaceuticals, inaddition to dozens of patient advocacyorganizations, praised the proposed leg-islation. “Innovative radiopharmaceuti-cals are revolutionizing the diagnosisand treatment of a wide varietyof diseases, but under current CMSpayment policies, these remarkableagents often are not available toMedicare beneficiaries, resulting ininequities in health care. The FINDAct addresses this current importantproblem and will improve access tothese life-saving imaging agents,”said Richard Wahl, MD, presidentof SNMMI.

“America leads the world in medi-cal research and innovation—but fartoo often, patients are unable to accessthe benefits of innovative medical tech-nologies because of outdated Medicarereimbursement policy,” added Repre-sentative Dunn at the act’s introduction.“The FIND Act is a common-sense,bipartisan proposal to address these cur-rent reimbursement problems, givingpatients access to the diagnostic toolsthey need, when they need them. Earlydetection saves lives and we must dowhat we can to expand access to theselife-saving tools.”

On August 4, Senators MarshaBlackburn (R-TN) and Tammy Bald-win (D-WI) introduced a companionbill in the U.S. Senate (S. 2609).“Innovative technology like diagnosticradiopharmaceuticals are importanttools in detecting and treating diseasessuch as cancer and Alzheimer’s,” saidSenator Blackburn. “The FIND Actwould increase patient access tomore cost-effective treatment optionswhile promoting further research and

development opportunities for medicalmanufacturers.”

The FIND Act addresses structuralissues in the packaging methodologyused in the Medicare outpatient settingby directing the Department of Healthand Human Services to pay separatelyfor all diagnostic radiopharmaceuticalswith a cost threshold per day of $500.If passed, this bill would give patientsgreater access to a wide range of diag-nostic radiopharmaceuticals that canbetter detect conditions such as heartdisease, Alzheimer and Parkinson dis-ease, breast and prostate cancer, andneuroendocrine tumors. This legisla-tion would also help providers bettermanage costs while delivering moretargeted and cost-efficient care.

For more information on the FINDAct, including avenues for advocacy,please see: https://www.snmmi.org/IssuesAdvocacy/content.aspx?ItemNumber=34002&navItemNumber=34003.

SNMMI

New NIA Alzheimer TrialRecruitment Tool

The National Institute on Aging(NIA) announced on July 30 at theannual meeting of the Alzheimer’sAssociation International Conference anew online research tool to helpincrease participation by traditionallyunderrepresented populations in clini-cal trials focusing on Alzheimer dis-ease (AD) and related dementias.Called Outreach Pro, the tool willenable researchers to create and cus-tomize participant recruitment commu-nications, such as websites, handouts,videos, and social media posts.

“We are facing a critical and grow-ing need for people living with Alz-heimer’s and related dementia, as wellas those at higher risk, and healthy peo-ple, to participate in clinical trials,” saidNIA Director Richard J. Hodes, MD.“That need is especially acute for fre-quently underrepresented groups suchas Black and Hispanic Americans,which is why Outreach Pro includes anemphasis on helping clinical trial

18N THE JOURNAL OF NUCLEAR MEDICINE � Vol. 62 � No. 10 � October 2021

NEW

SLIN

E

researchers connect with these and otherimportant communities.”

Outreach Pro is one of a suite ofNIA efforts to implement the NationalStrategy for Recruitment and Partici-pation in Alzheimer’s and RelatedDementias Clinical Research (2018).To use Outreach Pro, researchers andclinicians first select desired templateswith 1 of 3 communication goals: (1)to educate about AD, related demen-tias, and/or brain health; (2) to increaseawareness and interest in AD andrelated dementias clinical trials; or (3)to provide information about a specificAD or related dementia clinical trialcurrently enrolling participants. Eachtemplate can be customized using acentral library of messages, headlines,photos, and text that have been testedin individuals representing diverse andunderserved populations. The materi-als will be available initially in Englishand Spanish, with plans for addingAsian American and Pacific Islanderresources and languages later in 2021.Materials for American Indian andAlaska Native communities will bedeveloped and added in 2022. NIAdeveloped Outreach Pro and its con-tent systematically by using literaturereviews, environmental scans, listen-ing sessions with stakeholders, focusgroups, national surveys, and user test-ing. NIA plans to add content and scaleup the tool’s capabilities based on feed-back and performance measurement.

In total, NIA is currently support-ing 270 AD and related dementia clini-cal trials. Additional information onOutreach Pro is available at: https://outreachpro.nia.nih.gov/.

National Institute on Aging

NIH Expands BiomedicalResearch in the Cloud

The National Institutes of Health(NIH) announced on July 10 that Micro-soft Azure had joined the NIH Scienceand Technology Research Infrastructurefor Discovery, Experimentation, andSustainability (STRIDES) Initiative asthe newest cloud service provider tosupport biomedical research. Google

Cloud and Amazon Web Servicesjoined the initiative in 2018. TheSTRIDES Initiative aims to acceleratebiomedical research in the cloud byreducing economic and process barriersas well as providing cost-effectiveaccess to cloud platforms, training,cloud experts, and best practices foroptimizing research.

The initiative has alreadyexpanded access to critical infra-structure and cutting-edge cloudresources for NIH researchers, aswell as NIH-funded investigators atmore than 2,500 academic institu-tions across the United States. Todate, NIH has helped more than 425research programs and projectsleverage cloud resources through theSTRIDES initiative. Researchershave collectively used more than 83million h of computational resourcesto access and analyze more than 115petabytes of high-value biomedicaldata in the cloud. By leveraging theinitiative, the National Library ofMedicine’s Sequence Read Archive(among the world’s largest publiclyavailable genome sequence reposito-ries) migrated more than 43 peta-bytes of next-generation sequencingdata to the cloud, easing access formillions of researchers. Researcherscan now search the entire catalogof genomic data and take advantageof the computational tools foranalysis.

A central tenet of the STRIDESInitiative is that data made availablethrough these partnerships will incor-porate standards endorsed by the bio-medical research community to makedata findable, accessible, interoperable,and reusable (FAIR). “NIH has anambitious vision of a modernized,FAIR biomedical data landscape,” saidSusan K. Gregurick, PhD, associatedirector for Data Science and directorof the Office of Data Science Strategyat NIH. “By partnering with MicrosoftAzure, which has over 3 decades ofexperience in the cloud space, we canstrengthen NIH’s data ecosystem andaccelerate data-driven research and

discovery.” Additional information isavailable at: https://datascience.nih.gov/strides/.

National Institutes of Health

Medical Imaging RadiationLimits

On August 11 the American Asso-ciation of Physicists in Medicine(AAPM), the American College ofRadiology, and the Health Physics Soci-ety issued a joint statement in opposi-tion to cumulative radiation dose limitsfor patient imaging, citing potentialadverse effects on patient care. Thestatement comes in response to anopposing position by several organiza-tions and recently published papers onthe high-profile topic. According to thestatement “the decision to perform amedical imaging exam should be basedon clinical grounds, including the infor-mation available from prior imagingresults, and not on the dose from priorimaging-related radiation exposures.”In a related press release, AAPM statedits recommendation “against using dosevalues, including effective dose, from apatient’s prior imaging exams for thepurposes of medical decision-making.Using quantities such as cumulativeeffective dose may, unintentionally orby institutional or regulatory policy,negatively impact medical decisionsand patient care.” In addition, the posi-tion statement applied to “the use ofmetrics to longitudinally track apatient’s dose from medical radiationexposures and infer potential stochasticrisk from them.” It does not apply tothe use of organ-specific doses for pur-poses of evaluating the onset of deter-ministic effects (e.g., absorbed dose tothe eye lens or skin) or performing epi-demiologic research. The joint state-ment, a list of answers to frequentlyasked questions on the topic of medicalradiation safety, and a list of referencesto research papers supporting the signa-tories’ position is available at: https://www.aapm.org/org/policies/details.asp?id=1533.

American Association ofPhysicists in Medicine

Newsline 19N

NEW

SLIN

E

FDA and CollaborativeCommunities

The U.S. Food and Drug Adminis-tration (FDA) announced on August4 participation in several new “col-laborative communities” designed toaddress challenges in patient healthcare. Collaborative communities arecontinuing forums in which privateand public sector representatives worktogether on medical device challengesto achieve common objectives and out-comes. “We’re pleased to announcethe progress we’ve made with partici-pation in collaborative communities.These collaborations with diversestakeholders are not only a strategicpriority for the FDA’s Center for Devi-ces and Radiological Health, they alsoprovide much needed forums for deepdiscussion and solution-driven initia-tives to tackle important issues withinthe medical device ecosystem,” said JeffShuren, MD, JD, director of the Centerfor Devices and Radiological Health.“The insights and outcomes developedby these groups will have long-standingimpacts on public health.”

The FDA currently participates in12 collaborative communities, whichare established, managed, and controlledby external stakeholders. These com-munities are collectively charting pathsto accelerate and address regulatory

science and other knowledge gaps toaid in medical device review and over-sight. They may also impact the deliv-ery of health care and change clinicalcare paradigms. The most recent collab-orations focus on topics such as: medi-cal device development and productquality; understanding of valvular heartdisease; innovations in digital pathol-ogy; reducing rates of intended self-injury and suicidal acts by individualswith diabetes; and strategies to increasethe awareness, understanding, and par-ticipation of racial and ethnic minoritiesin the medical technology industry.

Collaborative communities are con-vened by interested stakeholders andmay exist indefinitely, produce deliver-ables as needed, and tackle challengeswith broad impacts. The FDA does notestablish, lead, or operate the communi-ties, nor are they intended to advise theFDA. Instead, the FDA may participatein the community to contribute itsknowledge and perspective to discus-sions of public health challenges andsolutions. For more about the FDA andcollaborative communities, see: https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-health-care-challenges-together.

U.S. Food and DrugAdministration

Breast Cancer Risk in HealthProfessionals

In a study published on August 9ahead of print in the American Journalof Preventive Medicine, Shen et al.from the Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung MedicalUniversity Chung-Ho Memorial Hospi-tal, and Kaohsiung Medical University(Kaohsiung City, Taiwan) and the Min-istry of Labor (Taipei, Taiwan) reportedon a 35-year longitudinal study ofbreast cancer risk among health profes-sionals. The study included data from 4country-wide population-based data-bases in Taiwan, including matchedcohorts of 277,543 health professionalsand 555,086 non–health professionals.The researchers found that health pro-fessionals had a significantly higher riskof breast cancer and that this elevatedrisk was associated with birth age, jobtenure, rotating day/night work, andseveral specific health professionallicense types, including physician, phar-macist, registered nurse, midwife, medi-cal technologist, and psychologist. Theauthors suggested that regular ultra-sound for younger women health careprofessionals and mammography forthose older than 45 y should beconsidered.

American Journal of PreventiveMedicine

20N THE JOURNAL OF NUCLEAR MEDICINE � Vol. 62 � No. 10 � October 2021

NEW

SLIN

E