Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer

NATerminatedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

January 31, 2020

Study Completion Date

January 31, 2020

Conditions
Breast Cancer
Interventions
OTHER

MRI

High risk screening MRI will be performed as part of the patient's routine care.

OTHER

CESM

After the MRI is complete, the patient will be brought to the mammography department for the contrast enhanced mammogram. The contrast enhanced mammogram will be independently interpreted by two study radiologists (randomly assigned) who are blinded to the MRI. They will then compare to the MRI to determine clinical follow-up. Any finding seen on MRI will be followed according to the MR protocol. Any finding seen on CESM only, will have a diagnostic work-up with mammography and ultrasound. If this work-up is negative, then follow-up CESM exams will be performed. Each patient will be followed for 2 years to determine sensitivity and specificity for both modalities.

Trial Locations (1)

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GE Healthcare

INDUSTRY

lead

Beth Israel Deaconess Medical Center

OTHER