This trial compares restriction spectrum imaging (RSI) with conventional and abbreviated magnetic resonance imaging (MRI) in screening participants who may have breast cancer. MRI uses a strong magnet to produce detailed pictures of the inside of the body and RSI is a technique that aims to improve the pictures produced during a MRI exam. RSI may be a better way to screen for breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03495115.
PRIMARY OBJECTIVE:
I. To measure the diagnostic accuracy of breast restriction spectrum imaging (RSI) in comparison to conventional breast MRI (dynamic contrast-enhanced MRI with diffusion weighted imaging; DCE-MRI+DWI) for breast cancer screening.
SECONDARY OBJECTIVE:
I. To measure the diagnostic accuracy of RSI compared to that of abbreviated MRI (Ab-MRI) in breast cancer screening.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP 1: Participants receive gadolinium intravenously (IV) and undergo standard MRI (DCE-MRI+DWI) and Ab-MRI over 30 minutes.
GROUP 2: Participants undergo standard MRI and Ab-MRI as in Group 1 and RSI over 5 minutes.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorVandana Dialani