Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Mangane
A Multi-Center, Phase 2, Open Label, Ascending Dose Study to Evaluate the Safety and Efficacy of RVP-001 and to Identify an Appropriate Dose to Detect CNS Lesions in Adult Patients
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- RVP-001
What it measured
Main measures
Adverse Events
From time of dosing to 7 days post dose
SafetyLesion visualization criteria for RVP-001 enhanced MRI compared to unenhanced MRI
1 day
MRI lesionsLesion visualization criteria for RVP-001 compared to gadolinium-based contrast agent (GBCA)
1 day
MRI lesions
Who could take part
MS (type not specified) · 18 to 75
Show the full criteria
Inclusion criteria
1. Adults of all sexes, aged 18-75 years 2. Patients with known enhancing CNS lesions, including but not limited to gliomas, meningiomas, glioblastomas, schwannomas, brain metastases, multiple sclerosis lesions, that are on an ongoing follow-up MRI schedule 3. Patients who have had a GBCA-enhanced MRI within the past 14 days which demonstrated focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors, focal inflammatory disorders) including at least one enhancing lesion of minimum 5 mm (long axis) 4. Acceptable renal function
Exclusion criteria
1. Serious non-malignant disease that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor 2. Body mass index (BMI) greater than 35 3. Patients with clinically significant cardiac disease 4. MRI incompatibility
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This Phase 2 clinical trial will study RVP-001, a new manganese-based MRI contrast agent, in people who are known to have gadolinium-enhancing central nervous system (CNS) lesions, for example brain tumors or multiple sclerosis. The goal of this study is to assess safety, efficacy, and pharmacokinetics of RVP-001 at three dose levels. The study will also compare RVP-001 imaging to gadolinium-based contrast agent (GBCA) imaging. A single dose of RVP-001 will be administered to each subject. Subjects will have known gadolinium-enhancing CNS lesions and will have a gadolinium-based contrast agent-enhanced MRI of the brain 2-14 days before receiving RVP-001 with imaging. The ultimate goal of this research program is development of a gadolinium-free alternative to current general purpose MRI contrast agents.
Papers
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History
Started
Aug 2024
Main results due
Dec 2025
Finished
Dec 2025