Breast MRI for Early Detection of Breast Cancer in Thuringia

Condition(s) studied

Investigational drug(s) / intervention(s)

Breast MRI: Contrast-enhanced breast magnetic resonance imaging performed as the protocol-defined primary imaging examination for early detection of breast cancer instead of conventional mammography. MRI examinations were interpreted according to the assessment criteria specified in the original study protocol. Detailed MRI acquisition and interpretation parameters, including MRI system, field strength, breast coil, imaging sequences, contrast agent, reader characteristics, and assessment categories, will be retrieved from the original study documentation.

Study 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.

Eligibility

Primary outcome measure(s)

• Sensitivity of Breast MRI for Invasive Breast Cancer — Index MRI examination through 24 months after the index examination
  Sensitivity will be calculated as the proportion of participants with invasive breast cancer who had a positive index MRI examination: Sensitivity = true positives / (true positives + false negatives). Invasive breast cancer status will be determined using histopathological verification and longitudinal cancer ascertainment according to the prespecified composite reference standard. Sensitivity will be reported with a two-sided 95% confidence interval.

Trial sites (1)

More Jena University Hospital trials in Germany

Other trials for the same condition