NCT06322342

Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Reveal Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Central Nervous System (CNS) Lesions
• Brain Metastases
• Brain Neoplasms
• Brain Neoplasms, Benign
• Brain Tumor, Primary
• Brain Tumor, Recurrent
• Brain Tumors
• Brain Cancer
• Brain Tumor
• Brain Neoplasm, Primary
• Multiple Sclerosis
• Multiple Sclerosis Brain Lesion
• Neurofibroma
• Acoustic Neuroma
• CNS Tumor
• CNS Lesion
• CNS Metastases
• CNS Cancer
• CNS Lymphoma
• Von Hippel Lindau
• Meningioma
• Glioma
• Schwannomas
• Neuroinflammation
• Neoplasia

Interventions

Type	Name	Description
DRUG	RVP-001	MRI contrast agent

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2024-03-21
• Last updated: 2025-12-26

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study