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COMPLETED
NCT06010173
PHASE3

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

Sponsor: Guerbet

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2023-07-21

Completion Date

2025-05-06

Last Updated

2026-06-25

Healthy Volunteers

No

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.

Locations (27)

Meitetsu Hospital

Aichi, Japan

Fukuoka University Hospital

Fukuoka, Japan

Gifu University Hospital

Gifu, Japan

Gunma University Hospital

Gunma, Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan

Nakamura Memorial Hospital

Hokkaido, Japan

National Hospital Organization Shikoku Medical Center for Children and Adults

Kagawa, Japan

Kanagawa Children's Medical Center

Kanagawa, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Japan

Kyoto City Hospital

Kyoto, Japan

Tohoku University Hospital

Miyagi, Japan

Nara Medical University Hospital

Nara, Japan

Kawasaki Medical School Hospital

Okayama, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Tominaga Hospital

Osaka, Japan

Saitama Prefectural Children's Medical Center

Saitama, Japan

Shin-Kuki General Hospital

Saitama, Japan

Shizuoka General Hospital

Shizuoka, Japan

Hamamatsu University Hospital

Shizuoka, Japan

Jichi Medical University Hospital

Tochigi, Japan

Tokyo Shinagawa Hospital

Tokyo, Japan

Toho University Omori Medical Center

Tokyo, Japan

National Center for Child Health and Development

Tokyo, Japan

Tokyo Metropolitan Children's Medical Center

Tokyo, Japan

Kurobe City Hospital

Toyama, Japan

Yamaguchi University Hospital

Yamaguchi, Japan