Mangaciclanol for Brain Tumor Imaging
(LUMINA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new substance, mangaciclanol, to evaluate its effectiveness in imaging brain and body tumors during MRI scans. The initial Phase 2 part aims to determine the optimal dose of mangaciclanol, while Phase 3 will compare its effectiveness and safety to gadobutrol, a standard imaging agent. The trial seeks participants with known or suspected brain or body lesions who are scheduled for an MRI as part of their regular care. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in medical imaging.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot receive any non-study contrast agent within 72 hours before the first study MRI and until 24 hours after the second study MRI. Participants on stable doses of corticosteroids or maintenance chemotherapy can continue their treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mangaciclanol is generally well-tolerated, meaning it doesn't usually cause serious side effects. In past studies, no major negative reactions were reported, and participants did not experience unexpected or severe side effects. This suggests that the treatment is safe for people, at least based on those studies.
Mangaciclanol has undergone testing in several clinical trials. These trials aim to ensure its effectiveness and safety as an MRI contrast agent, which enhances the clarity of MRI scans. The U.S. Food and Drug Administration (FDA) has granted it a fast-track designation, indicating promise in early tests. However, as with any treatment, individual reactions can vary, so discussing any concerns with the trial coordinators is important.12345Why are researchers excited about this trial's treatments?
Mangaciclanol is unique because it offers a new approach to brain tumor imaging. Unlike the standard of care, which often uses gadobutrol, mangaciclanol provides an alternative contrast agent that could enhance imaging precision. Researchers are particularly excited about its potential to deliver clearer images of brain tumors, which could lead to more accurate diagnoses and treatment plans.
What evidence suggests that mangaciclanol is effective for brain tumor imaging?
Research has shown that mangaciclanol, a manganese-based contrast agent, could effectively enhance brain tumor imaging. Studies have found it performs as well as current gadolinium-based agents in improving MRI images. In this trial, participants will receive either mangaciclanol or gadobutrol to compare their effectiveness. Mangaciclanol is designed to help doctors better identify and understand abnormal tissue in the brain and body. Previous trials demonstrated that it is well tolerated, with no serious side effects reported, making it a promising option for those needing clearer and more detailed MRI scans.12678
Who Is on the Research Team?
Stephanie Van de Ven
Principal Investigator
GE Healthcare
Are You a Good Fit for This Trial?
This trial is for adults with known or suspected brain or body tumors who need a contrast-enhanced MRI. Participants must be stable, able to follow study procedures, and agree to use contraception if needed. People can't join if they have severe heart disease, kidney problems, are pregnant/breastfeeding, can't get an MRI, or recently had other contrast agents.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 2 Treatment
Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding to identify an optimized dose of mangaciclanol
Phase 3 Treatment
Prospective, multicenter, randomized, controlled, single-blind, cross-over to evaluate efficacy and safety of mangaciclanol-enhanced MRI
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mangaciclanol
Trial Overview
The study compares a new MRI contrast agent called mangaciclanol (GEH200486) with gadobutrol in adults needing enhanced MRIs for brain or body lesions. The trial has two parts: first finding the best dose of mangaciclanol, then comparing its safety and effectiveness against gadobutrol.
How Is the Trial Designed?
3
Treatment groups
Active Control
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.
Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence mangaciclanol (V2) followed by gadobutrol (V4)
Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence gadobutrol (V2) followed by mangaciclanol (V4)
Find a Clinic Near You
Who Is Running the Clinical Trial?
GE Healthcare
Lead Sponsor
Fotis Vlachos
GE Healthcare
Chief Marketing Officer since 2024
PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania
Peter J. Arduini
GE Healthcare
Chief Executive Officer since 2022
MBA from Northwestern University, BSc in Marketing from Susquehanna University
Citations
NCT07472491 | A Phase 2/3 Study on the Efficacy and ...
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 ...
A Phase 2/3 Study on the Efficacy and Safety of ...
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 ...
3.
itnonline.com
itnonline.com/content/ge-healthcare-first-patient-dosed-trial-manganese-based-mri-contrast-agentGE HealthCare: First Patient Dosed in Trial for Manganese ...
Mangaciclanol is intended for general-purpose MR imaging and demonstrates comparable relaxivity (the ability to enhance signal intensity) to ...
4.
appliedradiology.com
appliedradiology.com/articles/ge-healthcare-initiates-key-clinical-trial-for-manganese-based-mri-contrast-agentGE HealthCare Initiates Key Clinical Trial for Manganese ...
The Phase 1 trial of mangaciclanol has demonstrated its tolerability without serious adverse effects. As GE HealthCare continues with its ...
GE HealthCare Announces Phase I Results for a First-of-its ...
The results, which will be used to support ongoing clinical development, concluded that in a first-in-human study, this manganese-based contrast ...
6.
gehealthcare.com
gehealthcare.com/en-us/about/expanded-access-policy?srsltid=AfmBOorDEOhGxlmlpXEwxSGslvdvQAgT5233sQIRMUc9IzpadP0sYdsRExpanded Access Policy for Mangaciclanol
GE HealthCare is currently conducting clinical trials to evaluate the efficacy and safety of mangaciclanol, an MRI contrast agent.
Phase 2 Ascending Dose Safety and Efficacy Study of RVP ...
Subjects will have known gadolinium-enhancing CNS lesions and will have a gadolinium-based contrast agent-enhanced MRI of the brain 2-14 days ...
8.
auntminnie.com
auntminnie.com/clinical-news/mri/news/15823056/ge-healthcare-ge-healthcare-doses-first-patient-in-mri-contrast-trialGE HealthCare doses first patient in MRI contrast trial
Mangaciclanol has received fast-track designation from the U.S. Food and Drug Administration (FDA) for use in adults and pediatric patients ages ...
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