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NCT02633501 · ClinicalTrials.gov registry record · Phase 2
P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
A Phase 2 study, sponsored by Guerbet.
- Completed
- Registry status
- Phase 2
- Development phase
- 312
- Enrollment target
NCT02633501: Completed Phase 2 study, sponsored by Guerbet.
NCT02633501 is a Phase 2 study that has completed, run by Guerbet. The registered enrollment target is 312 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (135% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02633501, a Phase 2 study, has completed, sponsored by Guerbet.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 312 participants
- Enrollment target
Study Summary
The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW). Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose. This was a multi-center, international, prospective, double-blind, randomized, controlled, parallel dose groups, cross-over with comparator study in male and female subjects presenting with known or highly suspected focal areas of disruption of the Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.
Primary Outcome
The Contrast-to-Noise Ratio (CNR) was calculated from the signal intensity measurement of maximum 3 enhanced lesions by 3 independent blinded readers. Only lesions detected by both MRIs after lesion tracking were used. The difference in CNR was calculated as follow: CNR (P03277) - CNR (gadobenate dimeglumine).
Interventions
- DEVICE MRI
- DRUG Gadobenate dimeglumine
- DRUG P03277
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2016-06 |
| Est. Completion | 2018-01 |
| Phase | Phase 2 |
What the finished NCT02633501 record still lists
NCT02633501 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (135% higher).
The record links to 0 conditions, and to 3 interventions - of which MRI is the first listed.
NCT02633501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02633501 about?
NCT02633501 is a clinical study titled "P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)". The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW). Contrast to Noise Ratio (CNR), a well-know...
What is the current status of trial NCT02633501?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 312 participants. The study started on 2016-06. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02633501?
The interventions under investigation include: MRI (DEVICE), Gadobenate dimeglumine (DRUG), P03277 (DRUG).
Who is sponsoring clinical trial NCT02633501?
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 NCT02633501's enrollment target sits among peer trials
312 161st of 2000 higher than 1,839 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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