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

NCT01938157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-05-18

No results posted yet for this study

Summary

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

Interventions

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.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Cherie Kuzmiak, DO · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-01-31
Completion
2017-03-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01938157 on ClinicalTrials.gov