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NCT03986138 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
A Phase 3 study of Lesion in Body Region, sponsored by Guerbet.
- Completed
- Registry status
- Phase 3
- Development phase
- 324
- Enrollment target
- 20
- Study locations
NCT03986138: Completed Phase 3 study of Lesion in Body Region, sponsored by Guerbet.
NCT03986138 is a Phase 3 study of Lesion in Body Region that has completed, run by Guerbet. The registered enrollment target is 324 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03986138, a Phase 3 study of Lesion in Body Region, has completed, sponsored by Guerbet.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 324 participants
- Enrollment target
- 20
- Study locations
Study Summary
The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
Primary Outcome
The lesion visualization at patient level was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\],
Conditions Studied
Interventions
- DRUG gadopiclenol
- DRUG Gadobutrol 1 MMOLE/ML Intravenous Solution
Study Locations (20)
Other
- Acibadem City Clinic Tokuda Hospital Sofia - Sofia
- CHU - Angers
- CHU Beaujon - Clichy
- Hôpital Saint Louis - Paris
- Klinik für Diagnostische und Interventionelle Radiologie - Aachen
- Universitätsklinikum Halle - Halle
- Universitätsklinikum des Saarlandes - Homburg
- University Hospital Jena - Jena
- Somogy Megyei Kaposi Mor Oktato Korhaz - Kaposvár
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet - Szolnok
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - Naples
- Clinical Research Institute S.C. - Estado de México
- Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center - Monterrey
Alabama
- The University of Alabama at Birmingham - Birmingham
Connecticut
- UConn Health - University of Connecticut - Farmington
Illinois
- The University of Chicago Medical Center - Chicago
Massachusetts
- Boston Medical Center - Boston
Missouri
- University of Missouri Health System - Columbia
New York
- Montefiore Medical Center - The Bronx
Texas
- UT Health San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2019-08-27 |
| Est. Completion | 2020-12-09 |
| Phase | Phase 3 |
What the finished NCT03986138 record still lists
NCT03986138 is an interventional study that assigns participants to a tested intervention. The registered 324 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 (58% lower).
The record links to 1 condition, with Lesion in Body Region appearing as the primary indexed condition, and to 2 interventions - of which gadopiclenol is the first listed.
NCT03986138 names 20 study sites across 8 states, led by Other, Alabama, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03986138 about?
NCT03986138 is a clinical study titled "Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)". The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
What is the current status of trial NCT03986138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 324 participants. The study started on 2019-08-27. Estimated completion is 2020-12-09.
What conditions does trial NCT03986138 study?
This clinical trial studies the following conditions: Lesion in Body Region.
What interventions are being tested in trial NCT03986138?
The interventions under investigation include: gadopiclenol (DRUG), Gadobutrol 1 MMOLE/ML Intravenous Solution (DRUG).
Who is sponsoring clinical trial NCT03986138?
This trial is sponsored by Guerbet, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03986138 being conducted?
This trial has 20 study locations across Alabama, Connecticut, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03986138's enrollment target sits among peer trials
324 1079th of 2000 higher than 920 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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