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Search / Trial NCT03730051

Dotarem vs Gadobutrol Contrast for Breast MRI

Launched by UNIVERSITY OF MASSACHUSETTS, WORCESTER · Nov 1, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breast Mri Mammography Dotarem Contrast Gadobutrol Contrast Wash In/Wash Out Contrast Curve Contrast Enhanced Mri

ClinConnect Summary

This clinical trial is studying two types of contrast agents used during breast MRI scans: Dotarem and Gadobutrol (Gadavist). The goal is to see if Dotarem works just as well as Gadavist in helping doctors identify breast lesions, which can be important for diagnosing conditions like breast cancer. Women who are 18 years or older and are scheduled for a breast MRI with contrast may be eligible to participate. To join, participants should have had, or be likely to have, a breast tissue sample taken recently, with results available within six months.

If you choose to participate, you will be randomly assigned to receive either Dotarem or Gadavist during your MRI. The trial will look at the quality of the images and how helpful they are for diagnosis. It's important to note that pregnant women, those who have started treatment for breast cancer, and premenopausal women outside a specific time frame in their menstrual cycle cannot participate. This study is currently recruiting participants, and your involvement could help improve breast imaging techniques in the future.

Gender

FEMALE

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

About University Of Massachusetts, Worcester

The University of Massachusetts Worcester is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the university integrates cutting-edge scientific inquiry with a commitment to improving patient outcomes. Its collaborative approach engages a diverse range of experts, fostering interdisciplinary research that addresses pressing health challenges. With a focus on ethical standards and regulatory compliance, the University of Massachusetts Worcester plays a pivotal role in translating scientific discoveries into practical applications that enhance medical practice and patient care.

Locations

Worcester, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Nicholas Bloch, MD

Principal Investigator

UMASS Medical School

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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