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High-intensity focused ultrasound in breast pathology:
non-invasive treatment of benign and malignant* lesions B. Cavallo Marincola, F. Pediconi, M. Anzidei, E.Miglio, L. Di Mare, M. Telesca,M. Mancini,
G. D’Amati, M. Monti, C. Catalano and A. Napoli; Expert Rev. Med. Devices; 2014
Methods
Results
10 patients diagnosed with one or multiple fibroadenomas (12 FA treated in 10 sessions) were treated
with ultrasound-guided high intensity focused ultrasound (i.e. echotherapy)
Maximum diameter range : 19mm – 44mm (Median: 26.5)
Mean patient age: 26y [18-34]
Treatment on an outpatient basis and under local anesthesia and mild sedation
Rationale
Breast tumors, either benign of malignant, are commonly diagnosed during screening imaging
procedures.
Even if surgery is the treatment of choice, other forms of less invasive radical treatment are desirable.
High-intensity focused ultrasound (HIFU) is already established as a valid non-invasive technique that
ensures tumor ablation in various organs. The publication reports the use of echotherapy (ultrasound-
guided HIFU) for the ablation of fibroadenomas.
Mean treatment duration: 57.2 min [40-100]
No adverse events but mild swelling and hardness
of the treated area
None of the patients reported pain
Before After
Mean volume reduction over time (% vs. months)
US images of a breast fibroadenoma before and 3 months after echotherapy
Conclusion
Echotherapy has a strong potential role for the ablation of benign breast tumors in order to provide a
valid noninvasive alternative treatment for breast conservative surgery.
50%
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Baseline 3
Me
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%)
20-mm fibroadenoma 10-mm fibroadenoma
THERACLION SA - THC 901682-A * The technology developed by Theraclion (i.e. Echotherapy) is only indicated to treat benign breast lesions like fibroadenomas.
Months
Ultrasound-guided high-intensity focused ultrasound treatment
of breast fibroadenoma - a multicenter experience R. Kovatcheva, JN. Guglielmina, M. Abehsera, L. Boulanger, N. Laurent and E. Poncelet;
Journal of Therapeutic Ultrasound; 2015
Methods
Results
Multicenter, open label and prospective study
42 patients diagnosed with one or multiple fibroadenoma (51 FA treated among which 8 treated twice)
were treated with ultrasound-guided high intensity focused ultrasound (i.e. echotherapy)
Treatment performed on an outpatient basis under conscious sedation
Mean patient age: 32y [16-52]
Mean FA volume at baseline: 3.89ml [0.34 – 19.66]
Rationale
Breast fibroadenoma (FA) is the most common benign lesion, affecting women in about 10% during
their lifetime, usually occurring under the age of 30.
As a consequence of breast imaging development, benign epithelial diseases represent a growing
percentage of breast pathology diagnoses.
Before After
2.96 ml FA
Before After
8.14 ml FA
Volume reduction of 62.3% 12mo after echotherapy
Volume reduction of 73.5% 12mo after echotherapy
Mean volume reduction over time (% vs. months)
US images of two breast fibroadenomas before and 12 months after echotherapy
Conclusion
Echotherapy is effective in reducing the volume and clinical symptoms of fibroadenomas without
serious side effects. Echotherapy may become a noninvasive alternative to surgery.
0
-73% -81,3
-100
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-20
00 4 8 12 16 20 24 28 32 36
Unpublished data of patients
having reached the resp. f/u Me
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%)
Months
Complete disappearance of discomfort
after 12 months in all patients
Complete disappearance of FA-related pain
after 12 months in all patients
Treatment well tolerated by all the patients
No serious adverse event
Mean total procedure duration: 118min [60 – 255]
THERACLION SA - THC 901683-A
Benign Solid Thyroid Nodules: US-guided High-Intensity Focused
Ultrasound Ablation — Initial Clinical Outcomes
R. D. Kovatcheva, J. D. Vlahov, J. I. Stoinov, K. Zaletel; Radiology; 2015
Methods
Results
20 euthyroid patients diagnosed with a benign solitary or dominant thyroid nodule were treated in one
session with ultrasound-guided high intensity focused ultrasound (i.e. echotherapy)
Mean thyroid volume at baseline: 4.96 ml ± 2.79
Mean patient age: 44.5y [24-65]
Treatment on an outpatient basis and under conscious sedation
Rationale
The prevalence of thyroid nodules found by means of palpation is approximately 5%, but an estimated
50% of unselected populations have nodules that can be discovered at ultrasonography. 95% of all
thyroid nodules are benign.
Even if surgery is the treatment of choice, risks of complications lead to the development of various
non-surgical, minimally invasive techniques.
Mean procedure duration: 86.8min [37-152]
Treatment well tolerated by all the patients
No serious adverse event
Before echotherapy 1 month after
Mean volume reduction over time (% vs. months)
Color Doppler US images of longitudinal scan in a 42yo woman
Conclusion
Echotherapy is an effective and safe non-invasive treatment method for benign solid thyroid nodules.
Months
65.3% volume reduction 86.5% volume reduction 92.9% volume reduction
3 months after 6 months after
-48,7
-56
-70
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0 2 4 6 8 10 12 14 16 18 20 22 24
Mea
n v
olu
me
red
uct
ion
(%
)
Unpublished data of patients
having reached the resp. f/u
THERACLION SA - THC 901684-A
9 patients diagnosed with a single thyroid nodule (6 cold – 3 hot nodules) were treated in one session
with ultrasound-guided high intensity focused ultrasound (i.e. echotherapy)
Median thyroid volume at baseline: 3.5mL [0.8-7.7]
Median patient age: 52y [36-80]
Treatment on an outpatient basis and under local anesthesia
Volume reduction of benign thyroid nodules 3 months after a
single treatment with high-intensity focused ultrasound (HIFU) H. Korkusuz, N. Fehre, M. Sennert, C. Happel and F. Grünwald; Journal of Therapeutic Ultrasound; 2015
Methods
Results
Rationale
Thyroid nodules are common in western population, most being of a benign nature.
For many years, surgery and radioiodine therapy were the only options. Both procedures are costly and
the former is not without risk. Additional techniques that have been widely discussed. High-intensity
focused ultrasound (HIFU) (i.e. echotherapy) is a promising, non-invasive technique in treating benign
thyroid nodules (TNs). The aim of this study was to evaluate the efficacy of echotherapy.
Median volume reduction: 48,8% [11,4-75]
Very good acceptance of the treatment
No major complications
Median procedure duration: 62min [42-96]
Before echotherapy 3 month after
Median volume reduction over time (% vs. months)
Sonographical volume measurement of an exemplary thyroidal nodule
Conclusion
Echotherapy appears to be safe and effective for inducing nodular shrinkage.
Me
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n (
%)
64.7% volume reduction
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0
Baseline 3 months
Patient 1 Patient 2
Patient 3 Patient 4
Patient 5 Patient 6
Patient 7 Patient 8
Patient 9
Before echotherapy 3 month after
THERACLION SA - THC 901685-A
3 Months
12 patients diagnosed with a single thyroid nodule were treated in one session with ultrasound-guided
high intensity focused ultrasound (i.e. echotherapy)
Mean thyroid volume at baseline: 3.4mL [0.6-5.0]
Mean patient age: 56.9y [37-81]
Treatment on an outpatient basis and under local anesthesia
Localized thyroid tissue ablation by HIFU: Volume reduction,
effect on thyroid function and immune response H. Korkusuz, M. Sennert, N. Fehre, C. Happel and F. Grünwald; Röfo; 2015
Methods
Results
Rationale
Initial demonstration of thyroid nodule volume reduction by high intensity focused ultrasound has been
done.
The goal of this study is to assess the effectiveness of the treatment in reducing the volume while
preserving thyroid function as measured by immunological response.
Complete thyroid hormone status pre ablation, 24h and
3m post ablation showed no significant change in thyroid
function.
Antibodies measurement pre ablation, 24h and 3m post
ablation showed no clinically meaningful induced
immune response.
Preserved thyroid function and absence of immune response at 24 h and 3 months follow up
Conclusion
Echotherapy is safe, effective and easy to use for the treatment of benign thyroid nodules. The
procedure preserves thyroid function and there is no indication of related autoimmune diseases or
thyrotoxicosis. Volume reduction is significant and in most cases sufficient.
Thyroglobulin evaluation pre ablation, 24h and 3 months
post ablation demonstrate the efficacy of thyroid tissue
ablation
Efficacy of tissue ablation assessed
hTg serum levels
Parameter Baseline 24 hours after HIFU 3 months after HIFU
T3 [nmol/L] 1.7 (1.4 – 2.3) 1.7 (0.9 – 2.7) 1.5 (1 – 2.2)
T4 [nmol/L] 84 (69 - 144) 92 (74 – 146) 87 (60 – 164)
TSH [nE/L] 0.9 (0.5 – 5.6) 0.7 (0.1 – 3.0) 1.2 (0.1 – 1.8)
hTg [ng/mL] 29.6 (0.1 – 459) 72.01 (28.9 – 3431.0) 15.3 (0.09 – 155)
TPOAbs [nmol/L] 10 (6 – 1119) 12 (6 – 986) 7 (3 – 791)
TABs [U/mL] 9 (5 – 110) 7 (5 – 63) 9 (3 – 108)
TRAbs [IU/L] 0.02 (0 – 0.92) 0.30 ( 0 – 0.74) 0.3 ( 0 – 0;74)
THERACLION SA - THC 901686-A
2 groups of patients diagnosed with a benign solitary or dominant thyroid nodule were treated with
ultrasound-guided high intensity focused ultrasound (i.e. echotherapy) (group 1-12 pts) and with
moving-beam echotherapy (BEAMOTION - CE-pending) (group 2-11 pts)
Treatment has been performed on an outpatient basis and under conscious sedation.
Comparison of thyroid nodules treatment duration with
US-guided HIFU vs US-guided moving-beam HIFU (BEAMOTION)
Unpublished data – Originated from R. Kovatcheva clinical trials
Methods
Results
Rationale
Thyroid nodules are common in western population, most being of a benign nature.
However, various non-surgical thermoablation techniques have been developed to reduce the size of
thyroid nodules, among which high-intensity focused ultrasound (i.e. echotherapy). The latter is the first
and only non-invasive thermoablative method.
Previous procedure: 83 min [36– 144]
vs
BEAMOTION: 17 min [10-27]
Mean treatment duration
Conclusion
Several studies demonstrate that echotherapy is a safe and effective treatment for benign thyroid
nodules.
Echotherapy treatment with BEAMOTION reduces up to 5 times the treatment duration as compared
with traditional US-guided HIFU.
Tre
atm
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t d
ura
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n (
min
ute
s)
Previous procedure BEAMOTION 0,00
30,00
60,00
90,00
120,00
150,00
180,00
THERACLION SA - THC 901687-A