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

ClinicalTrials.gov ID: NCT06322342

Public ClinicalTrials.gov record NCT06322342. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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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

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT06322342
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Reveal Pharmaceuticals Inc.; Industry
Enrollment: 18 participants

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 14, 2024
Primary completion: Dec 18, 2025
Completion: Dec 18, 2025
Last update posted: Dec 25, 2025

2024 – 2025

United States locations

U.S. sites: 5
U.S. states: 4
U.S. cities: 4

Facility	City	State	ZIP	Site status
Yale New Haven Hospital	New Haven	Connecticut	06510	—
Massachusetts General Hospital	Boston	Massachusetts	02114	—
Brigham & Women's Hospital	Boston	Massachusetts	02115	—
University of Missouri	Columbia	Missouri	65212	—
Duke University Medical Center	Durham	North Carolina	27710	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06322342, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 25, 2025 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06322342 live on ClinicalTrials.gov.

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