An observational study in Breast Cancer, sponsored by Jena University Hospital. Active, not recruiting at 1 site in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Jena University Hospital · Observational
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.
This study's planned enrollment of 750 is above the median of 185 across 2,712 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Jena University Hospital is the lead sponsor of 64 studies on the registry; 20 are open to participants now.
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Women who participated in the original Thuringian breast MRI early detection study, in which breast MRI was used as the protocol-defined primary imaging examination for early detection of breast cancer instead of conventional mammography. All eligible participants from the original MRI early detection cohort will be considered for inclusion in the present retrospective diagnostic accuracy analysis. Diagnostic performance will be assessed using MRI findings, subsequent diagnostic assessment and histopathology, and longitudinal cancer ascertainment including population-based cancer registry data.
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Exclusion Criteria:
- MRI early detection examination not completed or technically non-evaluable.
Women who participated in the original Thuringian breast cancer early detection study and underwent breast MRI as the protocol-defined primary examination for early detection of breast cancer instead of conventional mammography. Diagnostic performance will be evaluated retrospectively using MRI findings, subsequent diagnostic assessment and histopathology, and longitudinal cancer ascertainment.
Diagnostic Test: 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.
Sensitivity of Breast MRI for Invasive Breast Cancer
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.
Time frame: Index MRI examination through 24 months after the index examination
Plan to share: No
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Started Jan 2018 (actual). Primary completion is estimated for Oct 2026, 105 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Jena University Hospital