Clinical trial · Interventional
Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study
- 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)
Purpose: The purpose of this pilot study is to evaluate whether MRI of the breasts with diffusion-weighted MR imaging can identify features more specific for breast cancer in women at high-risk of developing breast cancer. Participants: One hundred asymptomatic women at high-risk for breast cancer recommended for a clinical breast MRI identified through the UNC Breast Clinic will be consecutively recruited for this study. Procedures (methods): Each patient will undergo a clinical breast MRI and the addition of a single 90 second diffusion weighted sequence. A reader study will be conducted at UNC after the completion of patient accrual. The images will be analysed for lesions, enhancement patterns, diffusion weighted imaging data and correlated with any pathology or 1 year follow-up MRI exam. The study information will be entered into a secure database and analyzed.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusion-weighted MR imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High Risk Breast Cancer Patients
- description
- High Risk Breast Cancer Patients (all subjects)
- interventionNames
- Procedure: Diffusion-weighted MR imaging
Primary outcomes (1)
- measure
- Number of identified lesions
- timeFrame
- 1 year from screening imaging
- description
- Lesions will be identified by 5 trained radiologists in a reader study. The identification of lesions will be confirmed by pathologists, or if no biopsy is performed, then truth will be determined after a 1-year follow-up MRI/MRI DWI.
Secondary outcomes (1)
- measure
- A composite of the sensitivity, specificity, and AUC of contrast-enhanced MRI and diffusion MRI
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria 1. Women at high-risk of breast cancer with an order for a clinical screening breast MRI. 2. Asymptomatic women. 3. Able to provide informed consent. 4. At least 21 years of age. Exclusion Criteria 1. Women with symptom such as palpable mass or nipple discharge. 2. Women with MRI/MRA contraindications such as a cardiac pacemaker, and aneurysm clip, cochlear implants, and metal in the eyes. 3. Women who have had a moderate or severe contrast reaction to intravenous gadolinium-DTPA. 4. Women who are not able to give consent. 5. Women diagnosed with breast cancer within the last 6 months. 6. Women who are pregnant. 7. Male patients.
References
Publications (0)
Data not yet available