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Breast MRI showdown: which contrast agent is better?

NCT ID NCT03730051

Diagnosis Sponsor: University of Massachusetts, Worcester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compared two MRI contrast agents, Dotarem and Gadavist, in 300 women undergoing breast MRI. The goal was to see if Dotarem is as effective as Gadavist at enhancing breast lesions for clearer images. Participants were randomly assigned to receive one of the two agents, and radiologists graded the image quality. The results could help doctors choose the best contrast agent for breast cancer detection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gadoterate meglumine (Dotarem) and gadobutrol (Gadavist)
What this could lead to
If successful, this could show that Dotarem is as good as Gadavist for breast MRI, giving doctors more options for clear imaging.
What could go wrong
This is a completed Phase 4 study focused on image quality, not on curing or treating disease. The results may not change current practice significantly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

300 people

The number who actually took part.

Started

Mar 2021

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast disorder breast fibrocystic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast diseases

Contacts and locations

Locations

  • UMass Medical School

    Worcester, Massachusetts, 01655, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.