No phaseActive, not recruiting

Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography (TOSYMA)

Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening (TOSYMA)

Sponsor
University Hospital Muenster (Academic or other)
Enrolment
99,689 enrolled
Conditions
Breast Cancer Screening
Interventions
DBT+s2D; 2D-FFDM
Ages
adults, older adults
Registry
NCT03377036

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Detection rate of invasive breast cancers
  • Cumulative 24 months incidence of interval cancers

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered

Papers citing this trial