Breast Cancer
Conditions
Keywords
Breast magnetic resonance imaging, Diagnostic accuracy, Interval breast cancer, Breast cancer early detection
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.
Interventions
DIAGNOSTIC_TESTBreast 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.
Sponsors
Jena University Hospital
Landeskrebsregister Thüringen
Techniker Krankenkasse
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Contacts
STUDY_DIRECTORUlf Prof. Teichgräber, MD
Friedrich-Schiller-University Jena, Jena University Hospital
Outcome results
None listed