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

NCT01236781 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2025-03-05

Study results available
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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.

Conditions

  • Breast Neoplasms

Interventions

DEVICE

Screening Tomosynthesis

Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).

DEVICE

Diagnostic Tomosynthesis

Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).

Sponsors & Collaborators

  • Pennsylvania Department of Health

    collaborator OTHER_GOV

  • American College of Radiology

    lead OTHER

Principal Investigators

  • Emily F. Conant, MD · Hospital of University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-04
Primary Completion
2012-06-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01236781 on ClinicalTrials.gov