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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 is a Phase 4 study that has completed, run by Guerbet. The registered enrollment target is 279 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02034708
The ClinicalTrials.gov registry entry for NCT02034708 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Guerbet, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dotarem® is the first listed.
NCT02034708 reports 0 study locations.
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.
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