Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
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.
Timeline
- Start
- 2023-07-21
- Primary completion
- 2025-05-06
- Completion
- 2025-05-06
Outcome
Met primary endpoint
registry p <0.0001; Mean Difference (Net) 0.06 (95% CI -0.02 to 0.15) NCT06010173 ↗
registry p <0.0001; Mean Difference (Net) 0.04 (5% CI -0.07 to 0.14) NCT06010173 ↗
registry p <0.0001; Mean Difference (Net) 0.12 (95% CI 0.04 to 0.19) NCT06010173 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gadobutrol | Diagnostic / imaging agent | 0.1 unknown | Intravenous |
| Subject | Gadopiclenol | Diagnostic / imaging agent | 0.05 unknown | Intravenous |