High Risk Screening Breast MR Using a Rapid Imaging Exam

Mayo Clinic1 site in 1 country140 target enrollmentApril 2006

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Mayo Clinic
Enrollment: 140
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

February 2011

Last Updated

13 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•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:
•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%
•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)
•A known BRCA mutation
•A family member carrying a known BRCA mutation
•A personal history of a high risk breast lesion, including lobular carcinoma in situ and atypical hyperplasia
•A personal history of primary breast cancer (invasive or in-situ) treated with unilateral mastectomy
•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.

Exclusion Criteria

•They are unable to return in one year for follow-up exam
•Medical history includes:
•Previous breast cancer treated with breast conservation
•History of benign excisional biopsy in the previous 24 months
•History of a benign core needle biopsy or FNA in the previous 12 months
•History of metastatic cancer
•45 minute prone scan cannot be tolerated
•Pregnant, as a mammogram for correlation with MR is required
•History of breast MR in the last 6 months

Outcomes

Primary Outcomes

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