Clinical Trial

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

Study acronym: TOSYMA
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2017-12-13; most recent amendment 2026-01-21.
Status change: Recruiting → Active, Not Recruiting 2021-02-04
Status change: Not Yet Recruiting → Recruiting 2018-07-10
Trial Details
NCT Number NCT03377036
Lead Sponsor University Hospital Muenster
Collaborators: German Research Foundation
Conditions Breast Cancer Screening
Enrollment 99,689 participants
Start Date 2018-07-05
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-23