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NCT03730051 · ClinicalTrials.gov registry record · Phase 4
Dotarem vs Gadobutrol Contrast for Breast MRI
A Phase 4 study of Breast Diseases, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT03730051: Completed Phase 4 study of Breast Diseases, sponsored by University of Massachusetts, Worcester.
NCT03730051 is a Phase 4 study of Breast Diseases that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 300 participants, roughly in line with the 280-participant average among 8 other Breast Diseases trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03730051, a Phase 4 study of Breast Diseases, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Each MRI exam will be graded by two radiologists blinded to the contrast agent using a scale of 1-(Fail- No enhancement or inadequate enhancement of the tumor) to 5-(Excellent- Strong and divisive contrast enhancement of entire tumor when compared to background. Clear and obvious tumor borders.) for the contrast enhancement quality.
Conditions Studied
Interventions
- DRUG Gadobutrol
- DRUG Gadoterate meglumine
Study Locations (1)
Massachusetts
- UMass Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 4 |
What the finished NCT03730051 record still lists
NCT03730051 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 280-participant average among 8 other Breast Diseases trials with a reported enrollment target.
The record links to 1 condition, with Breast Diseases appearing as the primary indexed condition, and to 2 interventions - of which Gadobutrol is the first listed.
NCT03730051 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03730051 about?
NCT03730051 is a clinical study titled "Dotarem vs Gadobutrol Contrast for Breast MRI". 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 r...
What is the current status of trial NCT03730051?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2021-03-01. Estimated completion is 2025-12-31.
What conditions does trial NCT03730051 study?
This clinical trial studies the following conditions: Breast Diseases.
What interventions are being tested in trial NCT03730051?
The interventions under investigation include: Gadobutrol (DRUG), Gadoterate meglumine (DRUG).
Who is sponsoring clinical trial NCT03730051?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03730051 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03730051's enrollment target sits among peer trials
300 4th of 8 higher than 4 of 8 other Breast Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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