specification and testing of radiographic systems for ... · mdacc imaging physics 1 ut md anderson...

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Specification and Testing of Specification and Testing of Radiographic Systems For Breast BiopsyRadiographic Systems For Breast Biopsy

William Geiser, MS DABRWilliam Geiser, MS DABR

Senior Medical PhysicistSenior Medical Physicist

MDACC Imaging Physics1

UT MD Anderson Cancer CenterUT MD Anderson Cancer Center

IntroductionIntroduction

•• Types of specimen radiography systemsTypes of specimen radiography systems

•• The procedure The procedure –– getting the imagesgetting the images

•• Laws and regulationsLaws and regulations


Laws and regulationsLaws and regulations

•• TGTG--209 Proposed specifications and testing209 Proposed specifications and testing


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Mastectomy SpecimenMastectomy Specimen


Mastectomy Specimen ZoomedMastectomy Specimen Zoomed



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Contact RadiographContact Radiograph

24x30 cm cassette24x30 cm cassette


Segmental Mastectomy Gross specimen Segmental Mastectomy Gross specimen ImageImage


Patient Info


Patient Info

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Segmental SlicedSegmental Sliced


Segmental Sliced ZoomedSegmental Sliced Zoomed



Patient InfoPatient Info

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Why the sliced specimenWhy the sliced specimen

•• Radiological and pathological size estimations of pure Radiological and pathological size estimations of pure ductal carcinoma in situ of the breast, specimen ductal carcinoma in situ of the breast, specimen handling and the influence on the success of breast handling and the influence on the success of breast conservation surgery: a review of 2564 cases from the conservation surgery: a review of 2564 cases from the Sloane Project.Sloane Project.


•• Thomas JThomas J, , Evans AEvans A, , Macartney JMacartney J, , Pinder SEPinder SE, , Hanby AHanby A, , Ellis IEllis I, , Kearins OKearins O, , Roberts TRoberts T, , Clements KClements K, , Lawrence GLawrence G, , Bishop HBishop H; ; Sloane Project Steering GroupSloane Project Steering Group..

•• The agreement between pathological and radiological size The agreement between pathological and radiological size of DCIS was poor in mastectomies but was improved by of DCIS was poor in mastectomies but was improved by specimen slice radiography, suggesting specimenspecimen slice radiography, suggesting specimen--handling handling techniques as a cause.techniques as a cause.

Stereotactic Breast BiopsyStereotactic Breast Biopsy


3 : 1 Magnification

18x24 cm CR Cassette


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Cabinet xCabinet x--ray systems are used to perform ray systems are used to perform radiography of breast specimens in both the radiography of breast specimens in both the stereotactic breast biopsy suite and in the operating stereotactic breast biopsy suite and in the operating room. What type of specimens are imaged in the room. What type of specimens are imaged in the operating room?operating room?

0%

0% 1.1. Stereotactic breast biopsy specimensStereotactic breast biopsy specimens


0%

0%

0%

0%

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2.2. Mastectomy specimensMastectomy specimens

3.3. Segmental mastectomy specimensSegmental mastectomy specimens

4.4. Ultrasound guided biopsy specimensUltrasound guided biopsy specimens

5.5. Both segmental and full mastectomy Both segmental and full mastectomy specimensspecimens

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AnswerAnswer

5 5 –– Both segmental and full mastectomy Both segmental and full mastectomy specimensspecimens


Ref: Ref: http://EzineArticles.com/?expert=Dr._Nithahttp://EzineArticles.com/?expert=Dr._Nitha_Thejal _Thejal

RegulationsRegulations

•• Current RegulationsCurrent Regulations–– FDAFDA

–– StateState


FDA StatementsFDA Statements

•• Some cabinet xSome cabinet x--ray systems are used for medical ray systems are used for medical applications, such as analyzing tissue samples for applications, such as analyzing tissue samples for tumor metastases. These systems are medical tumor metastases. These systems are medical devices and subject to additional FDA regulations.devices and subject to additional FDA regulations.


•• Use of cabinet xUse of cabinet x--ray products is regulated either by ray products is regulated either by the the U.S. Occupational Safety & Health U.S. Occupational Safety & Health AdministrationAdministration1111 or by State Government.or by State Government.

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Who regulates the QC testing required to be Who regulates the QC testing required to be performed on specimen xperformed on specimen x--ray systems?ray systems?

0%

0% 1.1. Food and Drug AdministrationFood and Drug Administration

22 N l R l t C i iN l R l t C i i


0%

0%

0%

0%

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2.2. Nuclear Regulatory CommissionNuclear Regulatory Commission

3.3. Individual State Radiation Control ProgramsIndividual State Radiation Control Programs

4.4. Mammography Quality Standards ActMammography Quality Standards Act

5.5. OSHAOSHA

AnswerAnswer

•• 3 3 –– Individual State Radiation Control Individual State Radiation Control ProgramsPrograms


•• Ref: 21 CFR 1020.40 : Ref: 21 CFR 1020.40 : http://www.fda.gov/Radiationhttp://www.fda.gov/Radiation--EmittingProducts/RadiationEmittingProductEmittingProducts/RadiationEmittingProductsandProcedures/SecuritySystems/ucm22719sandProcedures/SecuritySystems/ucm227196.htm6.htm

FDA FDA –– Code of Federal RegulationsCode of Federal Regulations

•• Cabinet XCabinet X--ray Systems ray Systems -- FDAFDA–– 21CFR1020.4021CFR1020.40

•• Radiation Emission LimitRadiation Emission Limit

FlFl


•• FloorsFloors

•• Ports and AperturesPorts and Apertures

•• InterlocksInterlocks

•• Ground FaultsGround Faults

•• Controls and IndicatorsControls and Indicators

•• Operating Procedures and Technical ManualsOperating Procedures and Technical Manuals

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Cabinet XCabinet X--ray Systemsray Systems

•• Texas RegulationsTexas Regulations–– 25 TAC 289.22825 TAC 289.228

•• This section establishes requirements for the use of This section establishes requirements for the use of industrial radiation machines not otherwise covered by thisindustrial radiation machines not otherwise covered by this


industrial radiation machines not otherwise covered by this industrial radiation machines not otherwise covered by this chapter. For purposes of this section, industrial radiation chapter. For purposes of this section, industrial radiation machines include, but are not limited to, portable/handheld machines include, but are not limited to, portable/handheld fluorescence xfluorescence x--ray (open beam), fluoroscopy hand held ray (open beam), fluoroscopy hand held intensified, fluoroscopy xintensified, fluoroscopy x--ray, industrial accelerator, ray, industrial accelerator, spectrography xspectrography x--ray, flash xray, flash x--ray, flash xray, flash x--ray for bomb ray for bomb detection, educational facility (xdetection, educational facility (x--ray for nonray for non--human or not human or not live animal use), diffraction xlive animal use), diffraction x--ray, uncertified cabinet xray, uncertified cabinet x--ray, ray, and minimal threat radiation machinesand minimal threat radiation machines

•• No registrant shall permit any individual to operate a No registrant shall permit any individual to operate a cabinet xcabinet x--ray system until the individual has received a ray system until the individual has received a copy of and instruction in the operating procedures for the copy of and instruction in the operating procedures for the unit.unit.

•• Tests for proper operation of interlocks shall be conductedTests for proper operation of interlocks shall be conducted


Tests for proper operation of interlocks shall be conducted Tests for proper operation of interlocks shall be conducted and recorded at intervals not to exceed 12 monthsand recorded at intervals not to exceed 12 months

•• The registrant shall perform an evaluation to determinate The registrant shall perform an evaluation to determinate compliance with compliance with §§289.231(o)(1)289.231(o)(1)--(3) of this title and Title (3) of this title and Title 21, CFR, 21, CFR, §§1020.40 at intervals not to exceed one year. The 1020.40 at intervals not to exceed one year. The registrant shall ensure that radiation emitted 5 centimeters registrant shall ensure that radiation emitted 5 centimeters from the external surface of the cabinet xfrom the external surface of the cabinet x--ray system does ray system does not exceed 0.5 millirem (5.0 mSv) in any one hour.not exceed 0.5 millirem (5.0 mSv) in any one hour.

•• (c)(c)RequirementsRequirements –––– (1)(1)Emission limit.Emission limit. (i) Radiation emitted from the (i) Radiation emitted from the

cabinet xcabinet x--ray system shall not exceed an ray system shall not exceed an exposure of 0 5 milliroentgen in one hour at anyexposure of 0 5 milliroentgen in one hour at any


exposure of 0.5 milliroentgen in one hour at any exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external point five centimeters outside the external surfacesurface

–– http://www.fda.gov/Radiationhttp://www.fda.gov/Radiation--EmittingProducts/RadiationEmittingProductsandProcedEmittingProducts/RadiationEmittingProductsandProcedures/SecuritySystems/ucm227196.htmures/SecuritySystems/ucm227196.htm

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•• (ii) Compliance with the exposure limit in paragraph (ii) Compliance with the exposure limit in paragraph (c)(1)(i) of this section shall be determined by (c)(1)(i) of this section shall be determined by measurements averaged over a crossmeasurements averaged over a cross--sectional area of ten sectional area of ten square centimeters with no linear dimension greater than 5 square centimeters with no linear dimension greater than 5 centimeters, with the cabinet xcentimeters, with the cabinet x--ray system operated at those ray system operated at those combinations of xcombinations of x ray tube potential current beamray tube potential current beam


combinations of xcombinations of x--ray tube potential, current, beam ray tube potential, current, beam orientation, and conditions of scatter radiation which orientation, and conditions of scatter radiation which produce the maximum xproduce the maximum x--ray exposure at the external ray exposure at the external surface, and with the door(s) and access panel(s) fully surface, and with the door(s) and access panel(s) fully closed as well as fixed at any other position(s) which will closed as well as fixed at any other position(s) which will allow the generation of x radiationallow the generation of x radiation

What is the maximum allowable exposure limit for What is the maximum allowable exposure limit for cabinet xcabinet x--ray systemsray systems

0%

0% 1.1. 0.05 mR in one hour0.05 mR in one hour

22 0 1 R i h0 1 R i h


0%

0%

0%

0%

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2.2. 0.1 mR in one hour0.1 mR in one hour


4.4. 0. 5 mR in one hour0. 5 mR in one hour


AnswerAnswer

•• 4. 0.5 mR in one hour4. 0.5 mR in one hour

•• Ref: 21CFR1020.40(c)(1)(i)Ref: 21CFR1020.40(c)(1)(i)


Ref: 21CFR1020.40(c)(1)(i)Ref: 21CFR1020.40(c)(1)(i)

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The MeasurementThe Measurement



Low Energy Window OpenLow Energy Window Open


Exposure MeasurementExposure Measurement

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Specification of Specimen XSpecification of Specimen X--ray systemsray systems

•• Must be FDA Approved!!Must be FDA Approved!!–– BiopticsBioptics

–– FaxitronFaxitron


–– KubtecKubtec

Stereotactic Breast Biopsy Specimen Stereotactic Breast Biopsy Specimen XX--ray Systemray System

•• XX--ray Tuberay Tube

•• MagnificationMagnification

•• Field SizeField Size


Field SizeField Size

Field SizeField Size

•• Large enough to image a 5 cm diameter Large enough to image a 5 cm diameter specimen dish at the proposed magnification specimen dish at the proposed magnification factorfactor

•• All systems at least 12 x 12 cmAll systems at least 12 x 12 cm


•• All systems at least 12 x 12 cmAll systems at least 12 x 12 cm

•• We use a 18 x 24 cm Mammography CR We use a 18 x 24 cm Mammography CR cassettecassette

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Specimen DishSpecimen Dish

4.8 cm


XX--ray Tube Specifications Cabinet ray Tube Specifications Cabinet SystemsSystems

Specification Faxitron MX 20 Bioptics Biovision Kubtec Xpert 40

kVp 10 kVp ‐ 35 kVp 5 kVp ‐ 45 kVp 10 kVp ‐ 50 kVp

mA 300 µA 1.5 mA 1.0 mA

Focal Spot < 20 µm 50 µm ?


Window Filtration 0.01 " Beryllium 0.125 mm Beryllium 0.005 mm Beryllium

Resolution 10 lp/mm 10 lp/mm ?

Active Imaging Area 12 cm x 12 cm10 cm x 15 cm, 12 cm x 18 cm

5 cm x 5 cm up to20 cm x 20 cm

Magnification ? 1:1, 2:1, 4:1 up to 5x

Specifications Core Biopsy SystemsSpecifications Core Biopsy Systems

Specification Faxitron DX ‐50 Bioptics Core Vision Kubtec Xpert 20

kVp 10 kVp ‐ 35 kVp 5 kVp ‐ 30 kVp 10 kVp ‐ 25 kVp

mA 0.1 mA 0.35 mA 1.0 mA

Focal Spot 50 µm ? ?


Window Filtration 0.03" beryllium 0.2 mm beryllium 0.005" beryllium

Resolution10 lp/mm or 20 lp/mm 35 micron ?

Active Imaging Area 5 cm x 5 cm 3 cm x 7 cm5 cm x 5 cm5 cm x 10 cm

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What is What is smallest detector size provided by any of the smallest detector size provided by any of the vendors for stereotactic core biopsy imaging?vendors for stereotactic core biopsy imaging?

0%

0% 1.1. 3 3 cm x cm x 7 cm (21 cm7 cm (21 cm22))

22 5 55 5 (25(25 22))


0%

0%

0%

0%

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2.2. 5 cm x 5 5 cm x 5 cm (25 cmcm (25 cm22))

3.3. 10 cm x10 10 cm x10 cm (100 cmcm (100 cm22))

4.4. 15 cm x15 15 cm x15 cm (225 cmcm (225 cm22))

5.5. 20 cm x 20 20 cm x 20 cm (400 cmcm (400 cm22))

AnswerAnswer

•• 1. 3 1. 3 cm x cm x 7 cm (21 cm7 cm (21 cm22))

•• RefRef:: Ref: Ref: BiopticsBioptics Core vision technical specifications: Core vision technical specifications: http://www biopticshttp://www bioptics--


http://www.biopticshttp://www.bioptics--inc.com/site/downloads/COREVISION_Brochure.pdf#zoom=60inc.com/site/downloads/COREVISION_Brochure.pdf#zoom=60

•• FaxitronFaxitron DXDX--50 Core Specimen Radiography System technical 50 Core Specimen Radiography System technical specifications: specifications: http://www.faxitron.com/pdf/Faxitron_DXhttp://www.faxitron.com/pdf/Faxitron_DX--50_Core_Datasheet.pdf50_Core_Datasheet.pdf

•• KubtecKubtec Xpert20 Specimen Radiography System technical Xpert20 Specimen Radiography System technical specifications: specifications: http://www.kubtec.com/xpert20.htmhttp://www.kubtec.com/xpert20.htm

QC Testing QC Testing –– AAPM TG 209AAPM TG 209

•• Proposed Proposed testingtesting–– Safety CheckSafety Check

–– kVpkVp


–– Exposure RateExposure Rate

–– Resolution Resolution -- DetectorDetector

–– Image quality phantomImage quality phantom

–– Film ProcessorFilm Processor

–– CR Reader CR Reader testingtesting

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EndEnd


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