Clinical trial · Observational
Non-contrast DWI for Supplemental Screening
Non-contrast DWI for Supplemental Screening of Women With Dense Breasts
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Diffusion-weighted imaging (DWI) is a short (under 5 minutes) non-contrast MRI technique that has shown promise for the detection and characterization of breast cancer. Our preliminary data has shown that DWI holds potential for detecting mammographically and clinically-occult breast cancers. However, current technical limitations reduce the sensitivity of DWI for screening applications. The identification of a screening tool to complement mammography that is more accurate than ultrasound and faster, less expensive, and safer than conventional contrast-enhanced MRI would have significant clinical impact by improving the early detection of cancer in women with dense breasts. We hypothesize that an optimized DWI approach will enable detection of mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate.
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 |
|---|---|---|---|
| Non-contrast DWI | Device | — | UNRESOLVED |
| Non-contrast MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Phase 1: Pilot Study Phase
- description
- Optimize DWI sequences to maximize spatial resolution, reduce distortion, and increase lesion contrast.
- interventionNames
- Device: Non-contrast DWI
- label
- Phase 2: Development Phase
- description
- Develop interpretation tools to optimize diagnostic performance for detecting cx on DWI.
- interventionNames
- Device: Non-contrast MRI
- label
- Phase 3: Reader Performance Phase
- description
- Test the performance of the optimized DWI approach for detecting clinically and mammographically-occult cancer in women with dense breasts.
- interventionNames
- Device: Non-contrast MRI
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 18 or older 2. Dense breast identified on mammogram Exclusion Criteria: 1. Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR\<60, contrast allergy, incompatible metal) 2. Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators) 3. Women who are pregnant
References
Publications (3)
- DERIVEDOviedo F, Kazerouni AS, Liznerski P, Xu Y, Hirano M, Vandermeulen RA, Kloft M, Blum E, Alessio AM, Li CI, Weeks WB, Dodhia R, Lavista Ferres JM, Rahbar H, Partridge SC. Cancer Detection in Breast MRI Screening via Explainable AI Anomaly Detection. Radiology. 2025 Jul;316(1):e241629. doi: 10.1148/radiol.241629. PMID 40662973
- DERIVEDBiswas D, Hippe DS, Wang Y, DelPriore MR, Zecevic M, Scheel JR, Rahbar H, Partridge SC. Accelerated Breast Diffusion-weighted Imaging Using Multiband Sensitivity Encoding with the CAIPIRINHA Method: Clinical Experience at 3 T. Radiol Imaging Cancer. 2022 Jan;4(1):e210063. doi: 10.1148/rycan.210063. PMID 35029517
- DERIVEDHa SM, Chang JM, Lee SH, Kim ES, Kim SY, Kim YS, Cho N, Moon WK. Detection of Contralateral Breast Cancer Using Diffusion-Weighted Magnetic Resonance Imaging in Women with Newly Diagnosed Breast Cancer: Comparison with Combined Mammography and Whole-Breast Ultrasound. Korean J Radiol. 2021 Jun;22(6):867-879. doi: 10.3348/kjr.2020.1183. Epub 2021 Apr 1. PMID 33856137