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Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography

NCT03377036 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99689

Last updated 2026-01-23

No results posted yet for this study

Summary

This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.

Conditions

  • Breast Cancer Screening

Interventions

DIAGNOSTIC_TEST

DBT+s2D

Digital breast tomosynthesis plus synthesized 2D mammograms

DIAGNOSTIC_TEST

2D-FFDM

2D full-field digital mammography

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Walter Heindel, MD, PhD · University Clinic for Radiology, University of Muenster / University Hospital Muenster

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Germany

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 NCT03377036 on ClinicalTrials.gov