Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01938157
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 55
- Starts
- 2013-08-01
- Expected to finish
- 2017-03-09
- Last updated by the study team
- 2017-05-18
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women at high-risk of breast cancer with an order for a clinical screening breast MRI.
- Asymptomatic women.
- Able to provide informed consent.
- At least 21 years of age.
You may not qualify if…
- Women with symptom such as palpable mass or nipple discharge.
- Women with MRI/MRA contraindications such as a cardiac pacemaker, and aneurysm clip, cochlear implants, and metal in the eyes.
- Women who have had a moderate or severe contrast reaction to intravenous gadolinium-DTPA.
- Women who are not able to give consent.
- Women diagnosed with breast cancer within the last 6 months.
- Women who are pregnant.
- Male patients.
Where it is running
- UNC Hospitals — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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