Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07881679

Breast MRI for Early Detection of Breast Cancer in Thuringia

Sponsor: Jena University Hospital

View on ClinicalTrials.gov

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.

Official title: Diagnostic Accuracy of Breast MRI as the Primary Modality for Early Detection of Breast Cancer in Thuringia: A Retrospective Registry-Linked Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

750

Start Date

2018-01-01

Completion Date

2026-10-31

Last Updated

2026-10-19

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (1)

Jena University Hospital, Department of Radiology

Jena, Thuringia, Germany