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Life sciences · Observational Study
ClinicalTrials.gov · October 19, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07881679). This is a study registration, not published results. Lead sponsor: Jena University Hospital. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 750 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: DIAGNOSTIC_TEST: Breast MRI. Primary outcome measures: Sensitivity of Breast MRI for Invasive Breast Cancer , Index MRI examination through 24 months after the index examination. Brief summary: 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.