Breast MRI for Early Detection of Breast Cancer in Thuringia

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.

Inclusion Criteria: * Breast MRI performed as the protocol-defined primary imaging examination for early detection of breast cancer instead of conventional mammography. * Evaluable breast MRI examination. * Adequate reference-standard information to determine breast cancer status. * A mammogram or ultrasound could not clearly show whether breast cancer has returned. This may be after breast-conserving treatment (surgery and/or radiotherapy) or after breast reconstruction. * A follow-up breast examination should be carried out every 2 years after the operation. * There is a familial risk, for example because first-degree relatives already have or have had breast cancer. * The mammogram cannot be interpreted because of dense breast tissue. Exclusion Criteria: \- MRI early detection examination not completed or technically non-evaluable. * Insufficient data to determine the MRI assessment. * Not a resident of Thuringia * Bilateral mastectomies * BIRADS 6 * Missing follow-up * Examination discontinued