High Risk Screening Breast MR Using a Rapid Imaging Exam

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00588614

Run by

Mayo Clinic

People needed

140

Starts

2006-04-01

Expected to finish

2011-02-01

Last updated by the study team

2012-05-30

Who can join

Age: 25 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Age 25-75
• Female

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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