acrin breast committee fall meeting 2010 4006: comparison of full-field digital mammography with...
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ACRIN Breast Committee
ACRIN Breast CommitteeFall Meeting 2010
4006: Comparison of Full-Field Digital Mammography with Digital Breast
Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate
Emily F. Conant, MD Constantine Gatsonis, PhD
ACRIN Breast Committee
ACRIN Breast Committee
Digital Breast Tomosynthesis
Disclosures:
GE Support (P.I. E. Conant): A Multicenter Study to Test the Non-Inferiority of Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography(FFDM) in Detecting Breast Cancer
E.Conant: Consultant to Hologic
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Study Summary
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Limitations of Mammography
Tissue superimposition
Projection Projection imagingimaging
DetectorDetector
BreastBreast
Compression Compression PlatePlate
X-raysX-rays
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Digital Breast Tomosynthesis (DBT)
Multiple low dose digital mammographic images are obtain along an arc and then reconstructed into a stack of images
Digital Breast Tomosynthesis
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Digital Breast Tomosynthesis
Tomographic Tomographic ImagingImaging
Tube Tube RotationRotation
DetectoDetectorr
BreastBreast
X-raysX-rays
Compression Compression PlatePlate
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Digital Breast Tomosynthesis
Vendors have varied approach to DBT:• Image acquisition
– Angle of acquistion, number of images in arc• Continuous arc image acquisition• “Stop and shoot” image acquisition
• Stand alone screening tool versus adjunct to full field digital mammography (FFDM)– Single view MLO DBT (no FFDM)– Two view DBT plus FFDM
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Digital Breast Tomosynthesis
• Preliminary experience has suggested that digital breast tomosynthesis (DBT) may provide:
– Better specificity leading to reductions in recall rates
– Improvements in sensitivity and the depiction of the extent of disease
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Digital Breast Tomosynthesis
Issues?• Few published trials • Results stress specifity as measured by reduction in
recall rates• Most are single institution, single vendor
– Technical approach varies greatly by vendor…
Little published data on impact of tomosynthesis on sensitivity in breast cancer screening
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Digital Breast Tomosynthesis
Multi-center trial of 1957 pts• Compared FFDM and DBT recall rates
– 43% reduction in recall rate Rafferty et al. RSNA 2007:SSG01-01
Single institution trial of 98 pts• Compared FFDM and DBT recall rate
- 40% reduction in recall ratePoplack et al. AJR
2007;189(3):616-623
Single institution trial of 125 selected studies• FFDM alone, DBT alone and FFDM/DBT combo
- 30% decrease recall rate with combo, 10% DBT aloneGur et al. AJR
2009;193:586-591
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Digital Breast Tomosynthesis
Two views versus one view tomo?• Results
– 22/34 (65%) both projections equal– 4/34 (12%) much better seen on MLO projection– 5/34 (15%) much better seen on CC projection– 3/34 (9%) seen only on the CC projection
Imaging in both CC and MLO positions is optimal
Rafferty et al:RSNA 2006;SSG01-04
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What about calcifications in DBT?
• 98 recalled cases– “image quality of tomosynthesis was inferior to
diagnostic mammography” in characterization of calcsPoplack et al. AJR
2007;189(3):616-623
• 119 DBT cases with calcifications– Approx. 50%, DBT = FFDM– Approx. 40%, DBT > FFDM
Kopans et al. RSNA 2008 SSJ01-02.
Motion artifact in DBT
Digital Breast Tomosynthesis
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Hypothesis
• Digital breast tomography (DBT) will improve the specificity of breast cancer screening as measured by a reduction in the call-back rate while maintaining the sensitivity of cancer detection. – This improved accuracy will be achieved by the
optimization of the imaging sequence and number of views obtained at a capped radiation dose in the combined DBT and 2-D screening sequence
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Eligibility and Sample Size
• Screening Group A (n=500) : – Women presenting for screening > 25 yrs
• Enrichment Group B (n=50) : – Women called back from FFDM screening for
diagnostic imaging
Total Accrual = 550 cases
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Study Design
• Standard of Care clinical study: – 3 view digital mammogram
• Study Imaging: – 2 view tomosynthesis (MLO and CC) and low dose 2-
D MLO– Sequential read of study low dose 2-D CC view.
Studies read independently therefore, call-backs determined independently
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Specific Aims
• Primary Aim: – Compare recall rates of FFDM to limited DBT set
(Group A)
• Secondary Aims: – To compare sensitivity of FFDM to the limited DBT
set (Groups A and B)
– To assess lesion-type characterization: • To compare sensitivity and specificity by lesion-type (calc only
lesions versus soft-tissue lesions, as well as lesion subgroups: masses, calcs, architectural distortions, asymmetries) in FFDM versus DBT.
• To estimate the agreement of FFDM and DBT with the determination of the adjudication committee on lesion-type characterization.
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Additional Aims
• Secondary Aims, continued: – To use the sequential interpretation results [Groups A and B] to
compare the two-view limited tomosynthesis set (with low-dose MLO view alone) with the tomosynthesis plus set (addition of low-dose CC view) on the basis of:
• Call-back rate;• Identification of new lesion(s);• Lesion characterization; and• Triangulation
– To calculate and compare the radiation dose of the FFDM and the DBT sets
– To identify the determinants of participant radiation dose and clinical image quality, including factors such as kVp, mAs, target/filter combination, and breast thickness and composition
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Recruitment
• Patients to be recruited over a 1 year period
• Trial scheduled to open 10/6/10 at Pennsylvania sites:
– Hospital of the University of Pennsylvania– Einstein Medical Center
• Limited to one industry since only one vendor in PA – Hologic
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Future Tomosynthesis Trials?
Optimize imaging for tomosynthesis• Which combinations of 3-D and possibly 2-D images?
• Decision based on risk/benefit for individual patient?
• Optimization of dose based on task?
Trial powered for sensitivity?• High/intermediate risk patients (+/-MR)?
How do we best utilize tomosynthesis for diagnostic imaging?