Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study

Enrollment and Recruitment:

A total of 100 high-risk women will be enrolled in this pilot study. High-risk for this study is defined as women at significantly increased risk of breast cancer. The Investigators will use the American Cancer Society Guidelines for Breast Screening with MRI as adjunct to mammography [2]. These guidelines recommend annual screening mammography for high risk women including BRCA mutations, first-degree relative of BRCA carrier, lifetime risk 20-25% or greater, previous history of chest radiation age 10 to 30 years and other syndromes related to increased breast cancer risk. We also included women with a history of previous high risk breast lesion(s) such as atypical hyperplasia, lobular carcinoma in situ or atypical lobular hyperplasia and a personal history of breast cancer by clinical consensus.

Patients who have been scheduled for the study will be contacted by research staff by phone to ask if they would be interested in participating in a research study. A script will be used to determine if patient is interested in hearing about a research study, if not the call will be discontinued immediately. If yes, more details will be provided to the patient to make a determination if they would like to participate.

If the patient is interested, she will be asked to come into the UNC MRI Department one hour prior to her scheduled MRI appointment. On the day of her MRI study, the patient will meet with the study coordinator or other assigned listed study personnel and will consent the subject to this study. Research coordinator/listed study personal will go through the consent form with the patient and answer any questions she may have. If patient agrees to participate after review of consent form, the patient will sign and date, the coordinator will then sign and date and patient will be formally enrolled. The patient will then undergo her ordered clinical breast MRI followed by one diffusion weighted MRI sequence.

Imaging Procedure: Each eligible patient, who provides consent for the study, will undergo a MR imaging screening questionnaire. If the patient has no contraindications, an intravenous line will be placed into a vein in the patient's arm and the patient will be placed prone with her breasts in a dedicated MRI breast coil. The patient will be given earplugs to decrease the noise level while in the magnet during the 45 minute total time period. High-resolution MRI sequences of the breasts and axillary regions will be performed before and after a gadolinium-DTPA bolus injection as per ordered clinical breast MRI protocol. Afterwards, one diffusion-weighted (DW) MRI sequence of the breast(s) will be performed. The DW sequence takes approximately 90 seconds.