Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07472491

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

Led by GE Healthcare · Updated on 2026-04-15

640

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is an adult of legal age according to local laws and can comply with study procedures
  • Participant has read, understood, signed, and dated the informed consent form before any study procedures
  • Participants in Phases 2 and 3 CNS have known or highly suspected enhancing CNS lesions based on recent imaging within 12 months
  • Phase 3 body participants have known or highly suspected enhancing lesions in at least one body region based on imaging within 12 months
  • Participant is scheduled for a contrast-enhanced MRI of the CNS or body for clinical reasons and agrees to a second MRI for the study
  • Participant is clinically stable with no acute deterioration within 48 hours before enrollment
  • Female participants are either surgically sterile, postmenopausal, non-lactating, or have negative pregnancy tests before IMP administration and agree to use adequate contraception if of childbearing potential
  • Male participants are surgically sterile, sexually active with a partner not of childbearing potential, or agree to use adequate contraception if with a partner of childbearing potential
Not Eligible

You will not qualify if you...

  • Participant has previously enrolled in this mangaciclanol study or earlier phase/cohort
  • Participant has contraindications to MRI such as pacemaker, certain metal foreign bodies, certain tattoos, severe claustrophobia, or occupational metal exposure without screening
  • Participant has severe cardiovascular disease or recent acute events such as myocardial infarction or stroke
  • Phase 2 only: Participant has estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2 within 14 days before first IMP dose
  • Phase 3 only: Participant has eGFR less than 30 mL/min/1.73 m2 within 14 days before first IMP dose
  • Participant has increased risk of hypersensitivity to mangaciclanol, gadolinium, or formulation components
  • Participant received any non-study contrast agent within 72 hours prior to first study MRI or plans to receive any during the trial until 24 ± 4 hours after second MRI
  • Participant received any investigational product within 30 days or 5 times half-life before or during the study
  • Participant is scheduled for treatments or procedures that might affect lesions from first MRI until 24 hours after second MRI, except stable corticosteroids or maintenance chemotherapy
  • Participant may not complete the study due to life expectancy or management concerns
  • Participant is pregnant, planning pregnancy, or breastfeeding
  • Participant unable or unlikely to comply with the protocol or follow-up visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

J

Jay Chahal

CONTACT

C

Catherine Copse

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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