Active — Not RecruitingNot Applicable

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

Germany99,689 participantsStarted 2018-07-05

Plain-language 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.

Who can participate

Age range50 Years – 69 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Breast cancer up to 5 years prior to study invitation * Previous mammography examination \< 12 months, * Breast implants

What they're measuring

Detection rate of invasive breast cancers

Timeframe: Routine screening visit

Cumulative 24 months incidence of interval cancers

Timeframe: 24 months after routine screening visit

Trial details

NCT IDNCT03377036

SponsorUniversity Hospital Muenster

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

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