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NCT07348640 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease
A Phase 3 study, sponsored by Guerbet.
- Not yet
- Registry status
- Phase 3
- Development phase
- 315
- Enrollment target
NCT07348640: Clinical Trial Phase 3 study, sponsored by Guerbet.
NCT07348640 is a Phase 3 study that has not yet begun recruiting, run by Guerbet. The registered enrollment target is 315 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07348640, a Phase 3 study, has not yet begun recruiting, sponsored by Guerbet.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 315 participants
- Enrollment target
Study Summary
Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI
Primary Outcome
To demonstrate the non-inferiority of gadopiclenol-enhanced Magnetic Resonance Angiography (MRA) compared to gadoterate meglumine enhanced MRA at 0.1 mmol/kg body weight in terms of sensitivity and specificity for detecting clinically significant steno-occlusive disease at segment level using Computerized Tomography Angiography (CTA) and/or Intra-arterial-Digital Subtraction Angiography (IA-DSA) findings as Standard of Truth.
Interventions
- DRUG gadopiclenol
- DRUG Gadoterate meglumine (Dotarem)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2026-02-02 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
What is known before NCT07348640 opens enrollment
NCT07348640 is an interventional study that assigns participants to a tested intervention. The registered 315 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 (59% lower).
The record links to 0 conditions, and to 2 interventions - of which gadopiclenol is the first listed.
NCT07348640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07348640 about?
NCT07348640 is a clinical study titled "Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease". Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI
What is the current status of trial NCT07348640?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2026-02-02. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT07348640?
The interventions under investigation include: gadopiclenol (DRUG), Gadoterate meglumine (Dotarem) (DRUG).
Who is sponsoring clinical trial NCT07348640?
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 NCT07348640's enrollment target sits among peer trials
315 1092nd of 2000 higher than 905 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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