Clinical trial · Observational
Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening
Development and Testing of an Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding obstacles
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abbreviated MRI Scan | Diagnostic Test | — | UNRESOLVED |
| MRI Abbreviated Scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Biopsy Group
- description
- We will scan 50 women who are scheduled for a breast biopsy. Subjects will receive an MRI exam that is research-only prior to the biopsy.
- interventionNames
- Diagnostic Test: MRI Abbreviated Scan
- label
- MRI Unknown Cancer Status Group
- description
- We will scan 150 women with dense breasts and/or women who have intermediate risk of breast cancer for this study. Subjects will receive an MRI exam that is research-only.
- interventionNames
- Diagnostic Test: Abbreviated MRI Scan
Primary outcomes (1)
- measure
- True Positive
- timeFrame
- 30 days
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Women that have had a mammographically and/or sonographically identified finding that will require image guided biopsy * Women between ages 40-74 with dense breasts having a mammogram * Women identified as having an average or intermediate risk of breast cancer (defined as 10- 20% lifetime risk based on a clinical risk model). Exclusion Criteria: * Women with metallic implants * Women that are claustrophobic * Women that have a fear of needles or contrast * Women that have had an allergic reaction to contrast in the past * Women that are pregnant * Women who are demonstrated to be at risk for an allergic reaction or nephrogenic systemic fibrosis (NSF)
References
Publications (1)
- DERIVEDOmoleye OJ, Esserman LJ, Olopade OI. RE: Supplemental magnetic resonance imaging plus mammography compared with magnetic resonance imaging or mammography by extent of breast density. J Natl Cancer Inst. 2024 Apr 5;116(4):627-628. doi: 10.1093/jnci/djae010. No abstract available. PMID 38281077