Last updated on November 2018

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

Brief description of study

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.

Detailed Study 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 cancers compared to 2D full-field digital mammography in routine screening according to the European Guidelines. Furthermore, the incidence rate of interval cancers within a 24 months interval after screening will be compared between both study arms in order to investigate the potential for overdiagnosis.

Clinical Study Identifier: NCT03377036

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Verantwortliche Studienärztin: Dr. med. Caroline ...

Screening-Einheit K ln rechtsrheinisch, Leverkusen, Rhein.-Berg. Kreis, Oberbergischer Kreis; Mammographie-Einheit Bergisch Gladbach
Bergisch Gladbach, Germany
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Recruitment Status: Open

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