High Risk Screening Breast MR Using a Rapid Imaging Exam

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588614
First received: December 26, 2007
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Risk Screening Breast MR Using a Rapid Imaging Exam

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: April 2006
Study Completion Date: February 2011
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

breast clinic patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588614

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

Additional Information:
No publications provided

Responsible Party: Elizabeth R. DePeri, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588614     History of Changes
Other Study ID Numbers: 363-06
Study First Received: December 26, 2007
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014