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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01938157
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Diffusion-weighted MR imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  1. Women at high-risk of breast cancer with an order for a clinical screening breast MRI.
  2. Asymptomatic women.
  3. Able to provide informed consent.
  4. At least 21 years of age.

Exclusion Criteria

  1. Women with symptom such as palpable mass or nipple discharge.
  2. Women with MRI/MRA contraindications such as a cardiac pacemaker, and aneurysm clip, cochlear implants, and metal in the eyes.
  3. Women who have had a moderate or severe contrast reaction to intravenous gadolinium-DTPA.
  4. Women who are not able to give consent.
  5. Women diagnosed with breast cancer within the last 6 months.
  6. Women who are pregnant.
  7. Male patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01938157

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United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Principal Investigator: Cherie Kuzmiak, DO University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01938157    
Other Study ID Numbers: 12-2327
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: April 2016
Keywords provided by University of North Carolina, Chapel Hill:
High Risk of Breast Cancer
Diffusion Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases