Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates

Study Overview
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Brief Summary
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This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening. Specificity, in this study, will be measured by the participant call-back rate by each modality. Varying combinations of 2-D mammography and tomosynthesis projections will be evaluated to optimize the screening paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective and retrospective imaging data will be assessed. 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.

Detailed Description
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Asymptomatic women 25 years and older with no history of breast cancer will be recruited from a prospective population of patients scheduled for screening mammography (Group A). A similar population of women called back from screening for 2-D FFDM-detected abnormalities will also be recruited to provide an enriched population of true-positive and false-positive 2-D FFDM and tomosynthesis cases (Group B). Pregnant women, women unable to tolerate compression of the breast associated with mammography, women with implants, and women with breasts too large to accommodate adequate positioning of the breast for DBT are excluded from trial participation. A total of 550 participants will be recruited--500 women will enroll for collection of prospective imaging data in this trial (Group A); 50 additional participants, recalled for diagnostic assessment after positive screening findings, will be recruited for DBT imaging data collection and retrospective image analysis (Group B). Participating institutions for this trial will be clinical research institutions in Pennsylvania with Hologic tomosynthesis units.

Official Title
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Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Device: Screening Tomosynthesis
* Device: Diagnostic Tomosynthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 25 years of age or older; No history of breast cancer; Group A only: Asymptomatic and scheduled for screening mammography; Group B only: Asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using FFDM, completed within 30 days prior to registration (BI-RADS 0: additional imaging needed); Willing to provide a written informed consent. Exclusion Criteria: Pregnancy or intent to become pregnant; Unable or unwilling to tolerate compression associated with mammography; Breast implants; Breasts too large to allow for adequate positioning for the DBT examination; Group B only: Patients with FFDM taken at screening who are unwilling or unable to submit images to ACRIN; Group B only: Unwilling to undergo tomosynthesis on both breasts as well as potentially additional diagnostic imaging based on tomosynthesis findings; Unable or unwilling to complete screening and (as necessary) diagnostic imaging at same facility; Tomosynthesis or mammography within 11 months prior to registration (excluding the screening mammography required for Group B).

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Screening<br>Group A comprises 500 asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM. | Device: Screening Tomosynthesis<br>* Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).<br>* Other names: Dimension;|
| Experimental: Group B: Diagnostic Enriched Population<br>Approximately 50 asymptomatic women with no history of breast cancer who have been informed of positive (abnormal) findings from a recent (within 30 days) FFDM screening will be recruited to Group B prior to their diagnostic imaging (e.g., diagnostic FFDM and/or ultrasound and/or other). | Device: Diagnostic Tomosynthesis<br>* Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).<br>* Other names: Dimension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Aim: Recall Rates | To compare recall rates of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Group A]. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Aim: Sensitivity | To compare sensitivity of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Groups A and B]. | 1 year | 
| Secondary Aim: Lesion-Type Characterization | To compare the sensitivity and specificity by lesion-type characterization (calcification-only lesions versus soft-tissue lesions, as well as lesion subgroups: masses, calcifications, architectural distortions, asymmetries) in FFDM versus DBT (two-view tomosynthesis set with low-dose MLO) [Group A call-back cohort and Group B]; To estimate the agreement of FFDM and DBT with the determination of the adjudication committee on lesion-type characterization. | 1 year | 
| Secondary Aim: Comparison of Views | To use the sequential interpretation results [Groups A and B] in order to compare the two-view limited tomosynthesis set (with low-dose MLO view alone) with the tomosynthesis plus set (low-dose MLO view plus addition of low-dose CC view) on the basis of: Call-back rate; Identification of new lesion(s); Lesion characterization; and Triangulation. | 1 year | 
| Secondary Aim: Radiation Dose | To calculate and compare the radiation dose of the FFDM and the DBT sets. | 1 year | 
| Secondary Aim: Radiation Dose and Quality | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, screening, diagnostics, diagnosis, high-risk, breast neoplasms, digital mammography, mammography, tomosynthesis, dense breasts, radiation dose, comparison, Hologic, Pennsylvania, Philadelphia, breast study, mammo, tomo, mammary