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Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

NCT06010173 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-05-20

No results posted yet for this study

Summary

This trial conducted in Japan includes 2 different cohorts of patients: adult patients and pediatric patients with two different designs.

* The cohort of adult patients has a prospective, multi-center, randomized, double-blind, controlled, and cross-over design.
* The cohort of pediatric patients has a prospective, multi-center, non-randomized, open-label and single arm design.

Primary objective to demonstrate the non-inferiority of gadopiclenol-enhanced MRI at 0.05 mmol/kg body weight (BW) compared to gadobutrol-enhanced MRI at 0.1 mmol/kg BW in terms of lesion visualization is applicable for adult patients referred for contrast-enhanced MRI of Central Nervous System (CNS) or Body regions.

Conditions

  • Lesion in Body Region
  • CNS Lesion

Interventions

DRUG

Gadopiclenol

Dose/volume of gadopiclenol to be administered will be calculated based on patient's weight at the dose of 0.05 mmol/kg BW

DRUG

Comparator

Dose/volume of comparator to be administered will be calculated based on patient's weight at the dose of 0.1 mmol/kg BW

Sponsors & Collaborators

  • Bracco Imaging S.p.A.

    collaborator INDUSTRY

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Toshiaki Taoka, MD · Nagoya University, JAPAN

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2025-03-26
Completion
2025-03-26

Countries

  • Japan

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 NCT06010173 on ClinicalTrials.gov