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

NCT07472491 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-05-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Dewen Yang, MD, PhD · GE Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Moldova

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07472491 on ClinicalTrials.gov