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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06322342.
Subjects may include individuals who have a stable primary brain tumor, metastatic brain
tumors, multiple sclerosis, or other gadolinium-enhancing CNS lesions. Following the
screening GBCA-enhanced MRI scan to confirm presence of target lesion(s), a baseline
unenhanced MRI scan will be performed prior to RVP-001 injection. Dynamic imaging will be
performed in conjunction with RVP-001 injection. Steady state imaging will follow at
multiple time points during the first hour following dose administration to characterize
the pharmacodynamics of RVP-001 and to assess its ability to enhance visualization of
areas with disrupted blood brain barrier and/or abnormal vascularity of the central
nervous system.
Three dose cohorts are planned.
An unenhanced MRI scan follow-up study will be performed between one week and six weeks
following the administration of RVP-001.
Safety will be evaluated throughout the study by assessing the following parameters:
adverse events (AEs), physical examinations, injection site monitoring,
electrocardiograms (ECGs), vital signs, clinical laboratory evaluations, medical history,
and prior and concomitant medications.
Lead OrganizationReveal Pharmaceuticals Inc.
Principal InvestigatorVera Hoffman
