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Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

NCT03986138 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-10-27

Study results available
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Summary

The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)

Conditions

  • Lesion in Body Region

Interventions

DRUG

gadopiclenol

Single intravenous bolus injection

DRUG

Gadobutrol 1 MMOLE/ML Intravenous Solution

Single intravenous bolus injection

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2020-12-09
Completion
2020-12-09
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • South Korea
  • Spain
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03986138 on ClinicalTrials.gov