At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
In Brief
A Phase 3 clinical trial evaluating Gadopiclenol and Comparator (gadobutrol) for Lesion in Body Region and CNS Lesion. Completed, enrolled 240 participants across 27 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent. Gadopiclenol and gadobutrol were injected as a single intravenous (IV) bolus injection at a recommended rate of approximately 2 mL/second followed by a 0.9% saline flush via manual injection or power injector. The injection rate should be identical for both products and might vary depending on scanned organ/region and age of patients.
Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent. Gadobutrol and gadopiclenol were injected as a single intravenous (IV) bolus injection at a recommended rate of approximately 2 mL/second followed by a 0.9% saline flush via manual injection or power injector. The injection rate should be identical for both products and might vary depending on scanned organ/region and age of patients.
Pediatric patients underwent one MRI examination with gadopiclenol. Gadopiclenol was injected in a single intravenous (IV) bolus injection at a recommended rate of approximately 2 mL/second followed by a 0.9% saline flush via manual injection or power injector.
Interventions
Dose/volume: Gadopiclenol administered was calculated based on patient's weight at the dose of 0.05 mmol/kg BW
Dose/volume of comparator: Gadobutrol administered was calculated based on patient's weight at the dose of 0.1 mmol/kg BW.