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

NCT01938157 | Completed

• 1 other identifier: 12-2327
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

High Risk of Breast Cancer; Diffusion Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Number of identified lesions

  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.

  1 year from screening imaging

Secondary Outcomes (1)

• A composite of the sensitivity, specificity, and AUC of contrast-enhanced MRI and diffusion MRI

  1 year following screening imaging

Study Arms (1)

High Risk Breast Cancer Patients

EXPERIMENTAL

High Risk Breast Cancer Patients (all subjects)

Procedure: Diffusion-weighted MR imaging

Interventions

Diffusion-weighted MR imaging PROCEDURE

An addition 90 seconds of DWI will be added to a clinical breast MRI for all patients agreeing to participate in the study.

High Risk Breast Cancer Patients

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cherie Kuzmiak, DO

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: September 10, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: March 9, 2017
• Last Updated: May 18, 2017

Record last verified: 2016-04

Locations

US (1)