Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer

Memorial Sloan Kettering Cancer Center1 site in 1 country1,000 target enrollmentOctober 2012

ConditionsWomen at Increased Risk for Developing Breast Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Women at Increased Risk for Developing Breast Carcinoma
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 1000
Locations: 1
Primary Endpoint: compare the sensitivity and specificity CESM
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM) will be able to detect smaller/earlier breast cancers as well as breast MRI can.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

June 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women considered at increased risk for developing breast carcinoma (those with a lifetime risk of \>15%due to family history, genetic predisposition, prior radiation therapy to the chest, prior biopsy showing a high risk lesion, or personal history of breast cancer) that are being screened with breast MRI.
•Women who have a screening digital mammogram on the day of CESM or within 365 days prior

Exclusion Criteria

•Women under
•Pregnant or possibly pregnant.
•Women who have a contraindication to the intravenous use of iodinated - contrast agent (i.e., allergy to iodinated contrastor severely impaired renal function with a creatinine level \> or = to 1.3).
•Women with breast implants.
•Women with pacemakers.
•Women with aneurysm clips that don't allow for MRI.
•Women too claustrophobic to undergo MRI.

Outcomes

Primary Outcomes

compare the sensitivity and specificity CESM

Time Frame: 1 year

CESM to that of breast MRI in a population of women who are being screened because they are at increased risk for developing breast cancer. For this purpose a positive CESM test will be defined as a score of 4 or 5. We will use the existing MRI BIRADS system to score CESM images based on the characteristics of individual lesions and increased enhancement compared to the background. A positive MRI test will be defined by a BIRADs score of 4 or 5.