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NCT02034708 · ClinicalTrials.gov registry record · Phase 4
Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
A Phase 4 study, sponsored by Guerbet.
- Completed
- Registry status
- Phase 4
- Development phase
- 279
- Enrollment target
NCT02034708: Completed Phase 4 study, sponsored by Guerbet.
NCT02034708 is a Phase 4 study that has completed, run by Guerbet. The registered enrollment target is 279 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02034708, a Phase 4 study, has completed, sponsored by Guerbet.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 279 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment). 270 patients will be randomized between 2 arms defining the sequence of administration of the contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14 days in between. Each patient will, therefore, receive two MRI during his/her participation in the study. The two arms consist in : * Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI. * Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI. Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems. MRI examinations will be evaluated centrally by blinded independent readers for the main evaluation criterion.
Primary Outcome
Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale: 0\. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and cha
Interventions
- DRUG Dotarem®
- DRUG Gadovist®/Gadavist®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
What the finished NCT02034708 record still lists
NCT02034708 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Dotarem® is the first listed.
NCT02034708 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02034708 about?
NCT02034708 is a clinical study titled "Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors". The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment). 270 patients will be randomized between 2 arms ...
What is the current status of trial NCT02034708?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 279 participants. The study started on 2014-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02034708?
The interventions under investigation include: Dotarem® (DRUG), Gadovist®/Gadavist® (DRUG).
Who is sponsoring clinical trial NCT02034708?
This trial is sponsored by Guerbet, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02034708's enrollment target sits among peer trials
279 305th of 2000 higher than 1,694 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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