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

CNS Lesion Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Adult cohort:

The trial includes a maximum of 5 visits and the record of patient's diagnosis as standard of truth:

• One screening visit (V1) up to 7 days prior to the imaging visit (V2) (V1 can be done on the same day as V2 if all the inclusion/non-inclusion criteria are met).

• Two sequential imaging visits (V2 and V4, minimum interval 2 days and up to 14 days):

each visit will consist of gadopiclenol injection or comparator injection and MRI procedure.

• Two safety visits (V3 and V5): 1 day after each injection and MRI examination.

Pediatric cohort:

The inclusions will be divided into 4 age groups: patients from birth to 23 months of age inclusive, patients from 2 to 6 years, patients from 7 to 11 years and patients from 12 to 17 years. The recruitment in the 3 older groups of pediatric patients can be conducted in parallel with adult patients' enrolment. The decision to start the inclusion in the group of patients aged from birth to 23 months will be taken by the Trial Safety Review Board (TSRB).

The trial includes a maximum of 3 visits and the record of patient's diagnosis as standard of truth:

• One screening visit (V1) up to 7 days prior to the imaging visit (V2) (V1 can be done on the same day as V2 if all the inclusion/non-inclusion criteria are met).

• One imaging visit (V2): will consist of gadopiclenol injection and MRI procedure.

• pharmacokinetics (PK) group: Blood sampling for PK will start after gadopiclenol injection according to defined blood sampling schedule and will take up to 8 hours.

• One safety visit (V3): 1 day after gadopiclenol injection and MRI examination.

All Patients:

Images will be assessed off-site in a centralized manner.

Pediatric group :

24 patients of the pediatric cohort will be included in gadopiclenol PK profile assessment.

The approach implemented for pharmacokinetics (PK) analyses allows sparse blood sampling only and is selected to minimize the clinical burden to children.

All cohorts :

During the trial, the safety of the patients will be monitored and assessed based on the reporting of adverse events (AEs), including vital signs, ECG for pediatric patients and clinical laboratory parameters (blood samples). ;

Related Conditions & MeSH terms

• CNS Lesion
• Lesion in Body Region

• NCT number: NCT06010173
• Study type: Interventional
• Source: Guerbet
• Contact: Anna Grinberg
• Phone: +33145915000
• Email: anna.grinberg@guerbet.com
• Status: Recruiting
• Phase: Phase 3
• Start date: July 21, 2023
• Completion date: December 2024