Skip to main content
OpenTrials
Completed

NCT Number: NCT00588614

High Risk Screening Breast MR Using a Rapid Imaging Exam

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Age 25-75
  • Female

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • GE Healthcare

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2011
First posted
Jan 8, 2008
Registry last updated
May 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.