High Risk Screening Breast MR Using a Rapid Imaging Exam

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: NCT00588614
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : May 30, 2012
GE Healthcare
Information provided by:
Mayo Clinic

Brief Summary:
This study is being done to find out if breast cancer detection will be improved using a short MRI (magnetic resonance imaging) scan, in addition to mammography, in patients who are at an increased risk of developing breast cancer.

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Risk Screening Breast MR Using a Rapid Imaging Exam
Study Start Date : April 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Secondary aim is to estimate the proportion of patients who go on to have a more comprehensive exam based on the results of the short exam. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
breast clinic patients

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

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): NCT00588614

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
GE Healthcare
Principal Investigator: Elizabeth R DePeri, MD Mayo Clinic

Additional Information:
Responsible Party: Elizabeth R. DePeri, MD, Mayo Clinic Identifier: NCT00588614     History of Changes
Other Study ID Numbers: 363-06
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012