Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study
|ClinicalTrials.gov Identifier: NCT01938157|
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : May 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Diffusion-weighted MR imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 9, 2017|
Experimental: High Risk Breast Cancer Patients
High Risk Breast Cancer Patients (all subjects)
Procedure: Diffusion-weighted MR imaging
An addition 90 seconds of DWI will be added to a clinical breast MRI for all patients agreeing to participate in the study.
- Number of identified lesions [ Time Frame: 1 year from screening imaging ]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.
- A composite of the sensitivity, specificity, and AUC of contrast-enhanced MRI and diffusion MRI [ Time Frame: 1 year following screening imaging ]Trained radiologists will complete a series of questionnaires about identified lesions. Using these questionnaires, a mixed-effect ANOVA model (Obuchowski and Rockette, 1995) is to fit these summary measures of diagnostics accuracy. To test the primary hypothesis , an approximately t-distributed statistic based on Obuchowski and Rockette (1995) will be used and we reject the hypothesis if the statistic is larger than 95% percentile of a central student's t-distribution with one degree of freedom.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938157
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Cherie Kuzmiak, DO||University of North Carolina, Chapel Hill|