Dotarem vs Gadobutrol Contrast for Breast MRI
Breast Diseases
About this trial
This is an interventional diagnostic trial for Breast Diseases focused on measuring Breast MRI, Mammography, Dotarem contrast, Gadobutrol contrast, wash-in/wash-out contrast curve, Contrast enhanced MRI
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- UMass Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Gadoterate meglumine contrast
Gadobutrol contrast
0.2 mL/kg (0.1 mmol/kg) administered as a single IV bolus injection at a rate of 2 mL/second. The FDA-approved product labeling provides weight-adjusted dose volumes as follows: 30 kg: 6 mL; 40 kg: 8 mL; 50 kg: 10 mL; 60 kg: 12 mL; 70 kg: 14 mL; 80 kg: 16 mL; 90 kg: 18 mL; 100 kg: 20 mL; 110 kg: 22 mL; 120 kg: 24 mL; 130 kg: 26 mL; 140 kg: 28 mL; 150 kg: 30 mL.
0.1 mL/kg (0.1 mmol/kg) administered as a single IV bolus injection by power injector. Imaging may begin after administration and then repeat sequentially to determine peak intensity and wash-out. The manufacturer provides weight-based dose volumes as follow: 35 kg: 3.5 mL; 40 kg: 4 mL; 45 kg: 4.5 mL; 50 kg: 5 mL; 60 kg: 6 mL; 70 kg: 7 mL; 80 kg: 8 mL; 90 kg: 9 mL; 100 kg: 10 mL; 110 kg: 11 mL; 120 kg: 12 mL; 130 kg: 13 mL; 140 kg: 14 mL.