NCT07472491

A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients

A Prospective, Multicenter Phase 2/3 Study to Assess the Efficacy and Safety of Mangaciclanol in Adult Patients With Known or Highly Suspected Lesions Referred for Contrast-Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) or Body (LUMINA)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 640 (estimated)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an operationally combined Phase 2/3 study, which will be conducted and evaluated in 2 distinct parts: * Phase 2: Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding, including participants with known or highly suspected lesions of the CNS. The aim of the Phase 2 part is to identify an optimized dose of mangaciclanol for the Phase 3 part of the study. * Phase 3: Prospective, multicenter, randomized, controlled, single-blind, cross-over, including participants with known or highly suspected lesions of the CNS or body. The aim of the Phase 3 part is to further evaluate the efficacy and safety of mangaciclanol-enhanced MRI for the detection and characterization of lesions of the CNS or body. The investigational medicinal products (IMPs) used during the trial are mangaciclanol and gadobutrol (comparator IMP). Primary and key secondary efficacy analyses will be based on independent central blinded image evaluation (BIE), and Phase 2 data will be analyzed prior to commencement of Phase 3.

Conditions

• Known or Highly Suspected Central Nervous System (CNS) Lesion
• Known or Highly Suspected Body (Excluding CNS) Lesion

Interventions

Type	Name	Description
DRUG	Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL	Single intravenous (IV) administration of Mangaciclanol (GEH200486 Injection, 0.5 mmol/mL) followed by a 20mL saline flush
DIAGNOSTIC_TEST	MRI Scan	MRI Scan starting prior to IMP administration and continuing for up to 60 minutes post IMP administration
DRUG	Gadobutrol	Single intravenous (IV) administration of Gadobutrol (0.1 mmol/kg) followed by a 20mL saline flush

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2026-03-16
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study