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NCT01236781 · ClinicalTrials.gov registry record · NA
Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
A NA study, sponsored by American College of Radiology.
- Completed
- Registry status
- NA
- Development phase
- 558
- Enrollment target
NCT01236781: Completed NA study, sponsored by American College of Radiology.
NCT01236781 is a NA study that has completed, run by American College of Radiology. The registered enrollment target is 558 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01236781, a NA study, has completed, sponsored by American College of Radiology.
- COMPLETED
- Registry status
- NA
- Development phase
- 558 participants
- Enrollment target
Study 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.
Primary Outcome
Each participant will undergo both FFDM and DBT examinations. Each of the two exams will be interpreted separately by readers at the participating sites and any positive finding for diagnostic followup will be considered a recall.
Interventions
- DEVICE Screening Tomosynthesis
- DEVICE Diagnostic Tomosynthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2011-01-04 |
| Est. Completion | 2013-12-31 |
| Phase | NA |
What the finished NCT01236781 record still lists
NCT01236781 is an interventional study that assigns participants to a tested intervention. The registered 558 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Screening Tomosynthesis is the first listed.
NCT01236781 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01236781 about?
NCT01236781 is a clinical study titled "Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates". 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 ra...
What is the current status of trial NCT01236781?
This trial is currently completed. It is a NA study. The enrollment target is 558 participants. The study started on 2011-01-04. Estimated completion is 2013-12-31.
What interventions are being tested in trial NCT01236781?
The interventions under investigation include: Screening Tomosynthesis (DEVICE), Diagnostic Tomosynthesis (DEVICE).
Who is sponsoring clinical trial NCT01236781?
This trial is sponsored by American College of Radiology, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01236781's enrollment target sits among peer trials
558 183rd of 2000 higher than 1,818 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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