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Dotarem vs Gadobutrol Contrast for Breast Cancer Imaging

Phase 4
Recruiting
Led By Nicholas Bloch, MD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing whether the MRI contrast agent Dotarem is as effective in contrast enhancement of breast lesions as Gadavist. Patients will be randomly assigned to receive either Dotarem or Gadavist, and image analysis will be performed to assess for differences in image quality and diagnostic value.

Who is the study for?
This trial is for women aged 18 or older who need a breast MRI with contrast and have had, or will likely have, a tissue sampling of the breast. It's not for pregnant women, those already treated for breast cancer, or premenopausal women outside of days 7-14 of their cycle.Check my eligibility
What is being tested?
The study compares two MRI contrast agents: Dotarem (Gadoterate meglumine) and Gadavist (Gadobutrol). Participants are randomly chosen to receive one of these agents to see if Dotarem is as effective in highlighting breast lesions as Gadavist.See study design
What are the potential side effects?
Potential side effects from both contrast agents may include allergic reactions, headache, nausea, dizziness, cold sensations at the injection site. These are generally mild but can vary among individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quality of breast MRI
Secondary outcome measures
Maximum enhancement slope for contrast breast MRI
Maximum relative enhancement (E(max) for contrast breast MRI
Time to peak enhancement (T(max)) for contrast breast MRI
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Gadobutrol contrastExperimental Treatment1 Intervention
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.
Group II: Gadoterate meglumine contrastActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadobutrol
2020
Completed Phase 3
~250

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
343 Previous Clinical Trials
986,352 Total Patients Enrolled
GuerbetIndustry Sponsor
68 Previous Clinical Trials
93,464 Total Patients Enrolled
Nicholas Bloch, MD5.01 ReviewsPrincipal Investigator - UMASS Medical School
University of Massachusetts, Worcester

Media Library

Gadobutrol Clinical Trial Eligibility Overview. Trial Name: NCT03730051 — Phase 4
Breast Disease Research Study Groups: Gadoterate meglumine contrast, Gadobutrol contrast
Breast Disease Clinical Trial 2023: Gadobutrol Highlights & Side Effects. Trial Name: NCT03730051 — Phase 4
Gadobutrol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03730051 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for patients to join this research trial?

"Affirmative. Clinicaltrials.gov indicates that this trial is actively enrolling patients, with a start date of March 1st 2021 and an update on June 1st 2022. The research team needs to select 258 participants from one medical site."

Answered by AI

How many test subjects have been recruited for this research endeavor?

"Affirmative. Clinicaltrials.gov shows that recruitment for this study is ongoing and began on March 1st 2021, with the latest update being June 1st 2022. The clinical trial requires 258 volunteers from a single site in order to continue."

Answered by AI

Could you elaborate on the research which has been conducted in regard to Gadobutrol?

"At this time, 7 trials are underway that research the effects of Gadobutrol. None have reached Phase 3 yet, however there are 40 study sites across America with a focus on Worcester, Massachusetts."

Answered by AI

What conditions is Gadobutrol conventionally used to treat?

"Gadobutrol is utilized in magnetic resonance angiography, as well as for the treatment of renal artery stenosis, breast diseases and MRI."

Answered by AI

What safety protocols must be followed when administering Gadobutrol?

"Our team has assigned Gadobutrol a score of 3, signifying that this medication is authorised for use due to the completion of Phase 4 trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dotarem vs Gadobutrol Contrast for Breast MRI
Gopal Vijayaraghavan 2021. "Dotarem vs Gadobutrol Contrast for Breast MRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03730051.
~54 spots leftby Mar 2025
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