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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 1, 2026

Status verified

Apr 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

640 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: Phase 2
  An initial dose of 0.1 mmol/kg mangaciclanol will be compared to the standard dose of gadobutrol (0.1 mmol/kg) in Cohort 1, in approximately 60 participants. A second cohort (Cohort 2) may be initiated based on the outcome of the analysis of Cohort 1. This cohort will include approximately 60 participants (higher or lower dose), or 30 participants (same dose), depending on the dose of mangaciclanol selected for further evaluation.
• Active Comparator: Phase 3 mangaciclanol-gadobutrol
  Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence mangaciclanol (V2) followed by gadobutrol (V4)
• Active Comparator: Phase 3 gadobutrol-mangaciclanol
  Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence gadobutrol (V2) followed by mangaciclanol (V4)

Primary Outcome Measure

Phase 2 Primary Endpoint - Overall diagnostic preference [ Time Frame: 4-47 days ]

Central Contacts

• Jay Chahal
  +44 7786702088
  [email protected]
• Catherine Copse

Locations (1)

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