Dotarem vs Gadobutrol Contrast for Breast MRI

Completed · Phase 4

Conditions studied: Breast Diseases

In brief

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.

Key facts

Study ID: NCT03730051
Run by: University of Massachusetts, Worcester
People needed: 300
Starts: 2021-03-01
Expected to finish: 2025-12-31
Last updated by the study team: 2026-03-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Females age 18 and older
Scheduled to undergo a clinically indicated MRI of the breast with contrast.
Have undergone, are scheduled to undergo, or are likely to be scheduled to undergo a breast tissue sampling exam with histology results available within 6 months of their MRI.

You may not qualify if…

Pregnant
Have already begun therapeutic treatment for breast cancer including surgery (lumpectomy or mastectomy), radiotherapy, or chemotherapy.
Pre Menopause women outside of the 7-14 days from cycle

Where it is running

UMass Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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