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High Risk Screening Breast MR Using a Rapid Imaging Exam

25 Years
75 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

High Risk Screening Breast MR Using a Rapid Imaging Exam

Inclusion Criteria:

1. High risk for the development of breast cancer. For the purposes of this study high
risk women will be defined as those having one of the following:

1. One or more first degree blood relative(s), maternal or paternal, with known
primary breast cancer, PLUS a Gail model calculated 5 year risk of greater than
or equal to 1.67%

2. First, and/or second degree blood relative(s) with a family history suggestive
of a BRCA mutation (those families having a member(s) with primary breast cancer
diagnosed at or before the age of 40, primary breast cancer and ovarian cancer
within the same family or family member, male relative with primary breast
cancer, a relative with bilateral breast cancer, or multiple generations of
family members with primary breast and/or ovarian cancer)

3. A known BRCA mutation

4. A family member carrying a known BRCA mutation

5. A personal history of a high risk breast lesion, including lobular carcinoma in
situ and atypical hyperplasia

6. A personal history of primary breast cancer (invasive or in-situ) treated with
unilateral mastectomy

2. Patients must have a mammogram performed within the last 6 months, and the
mammography images must be available for review at the time of the MR interpretation.

3. Age 25-75

4. Female

Exclusion Criteria:

1. They are unable to return in one year for follow-up exam

2. Medical history includes:

1. Previous breast cancer treated with breast conservation

2. History of benign excisional biopsy in the previous 24 months

3. History of a benign core needle biopsy or FNA in the previous 12 months

4. History of metastatic cancer

3. 45 minute prone scan cannot be tolerated

4. Pregnant, as a mammogram for correlation with MR is required

5. History of breast MR in the last 6 months

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The primary aim of the study is to estimate the negative predictive value (NPV) of the abbreviated exam for screening purposes, using a full length diagnostic study for confirmation and one year follow-up exams.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Elizabeth R DePeri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

February 2011

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Mayo ClinicJacksonville, Florida  32224