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First received: March 11, 2024

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

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Central Nervous System (CNS) Lesions

Study Type: INTERVENTIONAL


Official Title: 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

Brief 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…

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