Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01716247|
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Women at Increased Risk for Developing Breast Carcinoma||Other: Mammography (CESM) and MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Experimental: pts at risk for breast cancer
Women at increased risk for breast cancer who are being referred for screening MRI will be offered and consented for CESM at the same time. The 2 examinations will be performed on the same day when at all possible and if not we will make every attempt to perform CESM before MRI. Patients with outside MRI performed within 30 days and of adequate quality will also be eligible for CESM.
Other: Mammography (CESM) and MRI
The study consists of the addition of a single contrast enhanced digital mammography examination (CESM) to the routine screening of a woman at increased risk for breast cancer who is also having a breast MRI. Breast MRIs will be read by the radiologist reading breast MRIs on any given day. CESM is a dedicated system, derived from a standard digital mammography unit modified to deliver the dual or multiple energy exposures and visualization of combined images after IV contrast administration. If the patient is having her routine mammogram within 30 days of her MRI, CESM can replace that mammogram Patients will be randomly assigned to one of the radiologists trained to interpret CESM. That radiologist will read the CESM blinded to the results of the breast MRI.This process will be monitored by the research assistant No radiologist will read both the breast MRI and CESM on the same patient.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716247
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Maxine Jochelson, MD||Memorial Sloan Kettering Cancer Center|