Comparing two contrast agents for breast MRI
Official title: Contrast Enhanced Breast MRI: Comparison of Two Macrocyclic Gadolinium-Based Contrast Agents: Gadoterate Meglumine (Dotarem) and Gadobutrol (Gadavist). A Prospective Study.
Run by University of Massachusetts, Worcester · NCT03730051 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether two different contrast agents used in breast MRIs can help doctors see breast lesions better in women diagnosed with breast cancer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 258 (estimated) |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT03730051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are females aged 18 and older who are scheduled for a breast MRI with contrast and have relevant histology results available.
✕Probably not a fit
Patients who are pregnant or have already started treatment for breast cancer will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of two MRI contrast agents, Dotarem and Gadobutrol, in enhancing the visibility of breast lesions. Participants, primarily women diagnosed with breast cancer, will be randomly assigned to receive one of the two contrast agents during their clinically indicated breast MRI. The study will involve a detailed analysis of MRI images by blinded radiologists to assess the quality of contrast enhancement. Data will be collected from medical records and analyzed to determine any differences in diagnostic value between the two agents.
Why it matters
Potential benefit: If successful, this study could provide insights into which contrast agent offers better imaging quality for breast lesions, potentially improving diagnostic accuracy.
How similar studies have gone: Other studies have explored the effectiveness of different contrast agents in MRI, but this specific comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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UMass Medical School
Worcester, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Nicholas Bloch, MD — UMASS Medical School
- Study coordinator: Nicolas Bloch, MD
- Email: b.nicolas.bloch@umassmemorial.org
- Phone: 508-856-2144
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.