Breast MRI for Early Detection of Breast Cancer in Thuringia

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

  1. Minor Study First Submitted
Breast magnetic resonance imaging (MRI) has different diagnostic characteristics from conventional mammography and may detect breast cancers that are difficult to identify using mammography. In a predefined study population in Thuringia, Germany, breast MRI was performed as the primary imaging examination for early detection of breast cancer instead of conventional mammography. The primary purpose of this study is to assess the quality and performance of the MRI-based breast cancer early detection program. This retrospective diagnostic accuracy study will evaluate the performance of breast MRI using MRI data collected for early breast cancer detection, subsequent diagnostic assessment and histopathological data, and longitudinal population-based cancer registry information. The primary objective is to determine the sensitivity of breast MRI for detection of invasive breast cancer. Specificity, program sensitivity, interval breast cancer, predictive values, receiver operating characteristic measures, cancer detection and interval cancer rates, diagnostic assessment and biopsy rates, ductal carcinoma in situ, and tumor characteristics will be evaluated as secondary outcomes.
Trial Details
NCT Number NCT07881679
Lead Sponsor Jena University Hospital
Collaborators: Landeskrebsregister Thüringen, Techniker Krankenkasse
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov