Status:
ACTIVE_NOT_RECRUITING
Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
German Research Foundation
Conditions:
Breast Cancer Screening
Eligibility:
FEMALE
50-69 years
Phase:
NA
Brief 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-...
Detailed Description
The primary objective of the study is to evaluate whether digital breast tomosynthesis plus synthesized 2D mammograms leads to a relevant increase in the detection rate of screening-detected invasive ...
Eligibility Criteria
Inclusion
- Women eligible to participate in the National Mammography Screening Program of Germany
- Informed decision for mammography screening
- Written informed consent
- No prior participation in the TOSYMA trial
Exclusion
- Breast cancer up to 5 years prior to study invitation
- Previous mammography examination \< 12 months,
- Breast implants
Key Trial Info
Start Date :
July 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
99689 Patients enrolled
Trial Details
Trial ID
NCT03377036
Start Date
July 5 2018
End Date
March 31 2026
Last Update
December 2 2024
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Screening-Einheit Hannover; Mammographie-Einheit Hannover
Hanover, Lower Saxony, Germany, 30449
2
Screening-Einheit Niedersachsen Nordost; Mammographie-Einheit Lüneburg
Lüneburg, Lower Saxony, Germany, 21337
3
Screening-Einheit Niedersachsen Nord; Mammographie-Einheit Stade
Stade, Lower Saxony, Germany, 21680
4
Screening-Einheit Niedersachsen Mitte; Mammographie-Einheit Vechta
Vechta, Lower Saxony, Germany, 49377