In this randomized clinical trial, the investigators expect to demonstrate that the MRI
contrast agent Dotarem is not less effective in contrast enhancement of breast lesions then
Gadavist. Participants will be randomized to receive either Dotarem or Gadavist. In all
cases, inclusion criteria will require patients having undergone or scheduled or most likely
to be scheduled to undergo tissue sampling with histology results available. The patients
will be prospectively and consecutively identified such that the majority of patients
included will have been diagnosed with breast cancer, while including benign disease in the
minority of patients in each arm. Following randomized enrollment, quantitative,
semi-quantitative and qualitative image analysis will be performed to objectively assess for
differences in image quality and diagnostic value.
Phase:
Phase 4
Details
Lead Sponsor:
Boston Medical Center University of Massachusetts, Worcester