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ACTIVE NOT RECRUITING
NCT03377036
NA

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

Sponsor: University Hospital Muenster

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.

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

Key Details

Gender

FEMALE

Age Range

50 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

99689

Start Date

2018-07-05

Completion Date

2027-03-31

Last Updated

2026-01-23

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

DBT+s2D

Digital breast tomosynthesis plus synthesized 2D mammograms

DIAGNOSTIC_TEST

2D-FFDM

2D full-field digital mammography

Locations (21)

Screening-Einheit Hannover; Mammographie-Einheit Hannover

Hanover, Lower Saxony, Germany

Screening-Einheit Niedersachsen Nordost; Mammographie-Einheit Lüneburg

Lüneburg, Lower Saxony, Germany

Screening-Einheit Niedersachsen Nord; Mammographie-Einheit Stade

Stade, Lower Saxony, Germany

Screening-Einheit Niedersachsen Mitte; Mammographie-Einheit Vechta

Vechta, Lower Saxony, Germany

Screening-Einheit Niedersachsen Nordwest; Mammographie-Einheit Wilhelmshaven

Wilhelmshaven, Lower Saxony, Germany

Screening-Einheit Aachen-Düren-Heinsberg; Mammographie-Einheit Aachen

Aachen, North Rhine-Westphalia, Germany

Referenz-Screening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Ahlen

Ahlen, North Rhine-Westphalia, Germany

Screening-Einheit Köln rechtsrheinisch, Leverkusen, Rhein.-Berg. Kreis, Oberbergischer Kreis; Mammographie-Einheit Bergisch Gladbach

Bergisch Gladbach, North Rhine-Westphalia, Germany

Screening-Einheit Bielefeld, Gütersloh; Mammographie-Einheit Bielefeld

Bielefeld, North Rhine-Westphalia, Germany

Screening-Einheit Münster-Süd; Mammographie-Einheit Coesfeld

Coesfeld, North Rhine-Westphalia, Germany

Screening-Einheit Duisburg; Mammographie-Einheit Duisburg

Duisburg, North Rhine-Westphalia, Germany

Screening-Einheit Gelsenkirchen, Kreis Recklinghausen, Bottrop; Mammographie-Einheit Gelsenkirchen

Gelsenkirchen, North Rhine-Westphalia, Germany

Screening-Einheit Minden-Lübbecke, Herford; Mammographie-Einheit Herford

Herford, North Rhine-Westphalia, Germany

Screening-Einheit Mönchengladbach, Krefeld, Viersen; Mammographie-Einheit Krefeld

Krefeld, North Rhine-Westphalia, Germany

Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Lippstadt

Lippstadt, North Rhine-Westphalia, Germany

Referenz-Screeening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Münster-Nord

Münster, North Rhine-Westphalia, Germany

Screening-Einheit Münster-Süd; Mammographie-Einheit Münster

Münster, North Rhine-Westphalia, Germany

Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Paderborn

Paderborn, North Rhine-Westphalia, Germany

Screening-Einheit Märkischer Kreis, Hamm, Unna; Mammographie-Einheit Schwerte

Schwerte, North Rhine-Westphalia, Germany

Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Solingen-Mitte

Solingen, North Rhine-Westphalia, Germany

Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Wuppertal-Elberfeld

Wuppertal, North Rhine-Westphalia, Germany