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Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

NCT03996447 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-09-22

Study results available
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Summary

This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Conditions

  • CNS Lesion
  • Blood Brain Barrier Defect

Interventions

DRUG

gadopiclenol

single intravenous (IV) bolus injection at a rate of 2ml/second

DRUG

Gadobutrol 1Mmol/mL Solution for Injection Vial

single intravenous (IV) bolus injection at a rate of 2ml/second

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Lorie Loevner, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2020-09-11
Completion
2020-09-11
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • South Korea
  • Spain
  • Taiwan

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 NCT03996447 on ClinicalTrials.gov