High Risk Screening Breast MR Using a Rapid Imaging Exam
This study has been completed.
Sponsor:
Mayo Clinic
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
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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:
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
Contacts and Locations
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 May 16, 2013