High Risk Screening Breast MR Using a Rapid Imaging Exam

Breast Cancer Clinical Trial

Official title:

High Risk Screening Breast MR Using a Rapid Imaging Exam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588614
• Other study ID #: 363-06
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: May 29, 2012
• Start date: April 2006
• Est. completion date: February 2011

Study information

• Verified date: May 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2011
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No
Secondary	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.		2 years	No

External Links

•   Mayo Clinic Clinical Trials