Adults 40 to 74, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
True PositivePrimary· 30 days
The number of abbreviated scans that successfully determines a cancer, confirmed by biopsy, based on the radiologist determination that the MRI findings are suspicious. Suspicious lesions were assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0 (incomplete - need additional imaging evaluation), 4 (suspicious for malignancy - biopsy should be considered) and 5 (highly suggestive of malignancy - appropriate action should be taken).
Group
Value
95% CI
MRI Unknown Cancer Status Group
0.09
± 0.03
Sponsor's own description
The purpose of this study is to test an innovative MRI breast cancer screening method in women with mammographically dense breasts as well as other women with moderately increased cancer risk. MRI, combined with other methods of risk assessment, has potential to significantly improve sensitivity to cancer in dense breasts and detect cancer in all cases at a much earlier stage, with far fewer interval cancers than mammography. Previous tests of MRI sensitivity show that this screening could significantly increase the likelihood of detecting invasive cancers resulting in decreased mortality from breast cancer.
Suspicious lesions will be defined by the clinical interpretation of the breast MRI images performed by the attending breast radiologists. Based on the radiologist determination that the MRI findings are suspicious (these findings include masses, non-mass enhancement and foci), suspicious lesions will be assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0, 4 and 5. False positive diagnosis should be minimized as all attending physicians reading breast MRI at this institution are fellowship trained in breast imaging.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by University of Chicago
Last refreshed: 20 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04877912.