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Search / Trial NCT01236781

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

Launched by AMERICAN COLLEGE OF RADIOLOGY · Nov 8, 2010

Trial Information

Current as of July 21, 2025

Completed

Keywords

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

ClinConnect Summary

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 ...

Gender

FEMALE

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).

About American College Of Radiology

The American College of Radiology (ACR) is a leading professional organization dedicated to advancing the practice of radiology through education, research, and advocacy. Committed to improving patient care, ACR plays a pivotal role in setting standards for quality and safety in medical imaging and radiation therapy. As a sponsor of clinical trials, ACR focuses on promoting evidence-based practices and fostering innovation in radiological science, ensuring that research initiatives align with the highest ethical and scientific standards. Through collaboration with healthcare professionals, researchers, and institutions, ACR strives to enhance the effectiveness and efficacy of radiological services, ultimately benefiting patients and the broader healthcare community.

Locations

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Emily F. Conant, MD

Study Chair

Hospital of University of Pennsylvania

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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