N/A
N=558
Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01236781 ↗Enrolled (actual)
558
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Recall Rate in Group A Participants — 29; 34; 472; 467 Participants — p=0.46
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Screening Tomosynthesis (Device); Diagnostic Tomosynthesis (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- American College of Radiology
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recall Rate in Group A Participants |
29; 34; 472; 467 | 0.46 |
| SECONDARY Accuracy Based on Pathology Results |
3; 3; 4; 4; 1; 1 | — |
| SECONDARY Accuracy, Based on Pathology Results, by Lesion Classification |
5; 4; 14; 8; 19; 27 | — |
| SECONDARY Callback Rate of 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) |
34; 30; 29; 30; 467; 471 | 0.2188 |
| SECONDARY Radiation Dose |
1.79; 1.39; 1.84 | — |
| SECONDARY Regression Model Parameters for Factors Effecting Radiation Dose |
-3.1852; -5.3837; 0.01215; 0.009873; 0.1384; 0.2180 | — |
| SECONDARY Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) |
20; 22; 55; 53; 39; 37 | — |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01236781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.