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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 2026-06-25

Study results available
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Summary

GDX-44-014 - GDX-101 study was conducted in Japan including 2 cohorts (adult cohort for adult population and pediatric cohort for pediatric population), with different designs:

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

The primary objective was 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 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: Gadopiclenol administered was calculated based on patient's weight at the dose of 0.05 mmol/kg BW

DRUG

Comparator (gadobutrol)

Dose/volume of comparator: Gadobutrol administered was 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
2025-05-06
Completion
2025-05-06

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