ACTIVE_NOT_RECRUITING

Dotarem vs Gadobutrol Contrast for Breast MRI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Contrast Enhanced Breast MRI: Comparison of Two Macrocyclic Gadolinium-Based Contrast Agents: Gadoterate Meglumine (Dotarem) and Gadobutrol (Gadavist). A Prospective Study.

Quick Facts

Study Start:2021-03-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03730051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Females age 18 and older
  2. * Scheduled to undergo a clinically indicated MRI of the breast with contrast.
  3. * 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.
  1. * Pregnant
  2. * Have already begun therapeutic treatment for breast cancer including surgery (lumpectomy or mastectomy), radiotherapy, or chemotherapy.
  3. * Pre Menopause women outside of the 7-14 days from cycle

Contacts and Locations

Principal Investigator

Nicholas Bloch, MD
PRINCIPAL_INVESTIGATOR
UMASS Medical School

Study Locations (Sites)

UMass Medical School
Worcester, Massachusetts, 01655
United States

Collaborators and Investigators

Sponsor: University of Massachusetts, Worcester

  • Nicholas Bloch, MD, PRINCIPAL_INVESTIGATOR, UMASS Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-03-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Breast MRI
  • Mammography
  • Dotarem contrast
  • Gadobutrol contrast
  • wash-in/wash-out contrast curve
  • Contrast enhanced MRI

Additional Relevant MeSH Terms

  • Breast Diseases