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Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent
Trial Status: active
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.
Inclusion Criteria
Adults of all sexes, aged 18-75 years
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
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)
Acceptable renal function
Exclusion Criteria
Serious non-malignant disease that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor
Body mass index (BMI) greater than 35
Patients with clinically significant cardiac disease
MRI incompatibility
Additional locations may be listed on ClinicalTrials.gov for NCT06322342.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Temporarily closed to accrual
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Temporarily closed to accrual
Name Not Available
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,
