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NCT01211873 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
A Phase 3 study, sponsored by Guerbet.
- Completed
- Registry status
- Phase 3
- Development phase
- 416
- Enrollment target
NCT01211873: Completed Phase 3 study, sponsored by Guerbet.
NCT01211873 is a Phase 3 study that has completed, run by Guerbet. The registered enrollment target is 416 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01211873, a Phase 3 study, has completed, sponsored by Guerbet.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 416 participants
- Enrollment target
Study Summary
The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.
Primary Outcome
To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization. Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI. The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from
Interventions
- DRUG Dotarem (gadoterate meglumine)
- DRUG Magnevist (gadopentetate dimeglumine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01211873 record still lists
NCT01211873 is an interventional study that assigns participants to a tested intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Dotarem (gadoterate meglumine) is the first listed.
NCT01211873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01211873 about?
NCT01211873 is a clinical study titled "Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions". The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.
What is the current status of trial NCT01211873?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2010-09. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01211873?
The interventions under investigation include: Dotarem (gadoterate meglumine) (DRUG), Magnevist (gadopentetate dimeglumine) (DRUG).
Who is sponsoring clinical trial NCT01211873?
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 NCT01211873's enrollment target sits among peer trials
416 902nd of 2000 higher than 1,098 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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