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

December 23, 2025 updated by: Reveal Pharmaceuticals Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults of all sexes, aged 18-75 years
  2. 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
  3. 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)
  4. Acceptable renal function

Exclusion Criteria:

  1. Serious non-malignant disease that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor
  2. Body mass index (BMI) greater than 35
  3. Patients with clinically significant cardiac disease
  4. MRI incompatibility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 mg/Mn/kg
6 subjects each will receive RVP-001 at a dose of 2 mg Mn/kg
Drug: RVP-001
MRI contrast agent
Other Names:
  • Mn-PyC3A
  • mangaverate
Experimental: 7 mg/Mn/kg
6 subjects each will receive RVP-001 at a dose of 7 mg Mn/kg
Drug: RVP-001
MRI contrast agent
Other Names:
  • Mn-PyC3A
  • mangaverate
Experimental: 12 mg/Mn/kg
6 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg
Drug: RVP-001
MRI contrast agent
Other Names:
  • Mn-PyC3A
  • mangaverate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: From time of dosing to 7 days post dose
Treatment-emergent adverse events for each dose level will be summarized.
From time of dosing to 7 days post dose
Lesion visualization criteria for RVP-001 enhanced MRI compared to unenhanced MRI
Time Frame: 1 day
The lesion visualization criteria is based on 3 criteria: border delineation, lesion contrast, and internal morphology. These criteria will be assessed by independent readers for representative lesions using the images acquired during the MRI performed with RVP-001.
1 day
Lesion visualization criteria for RVP-001 compared to gadolinium-based contrast agent (GBCA)
Time Frame: 1 day

The lesion visualization criteria is based on 3 criteria: border delineation, lesion contrast, and internal morphology. These criteria will be assessed by independent readers for representative lesions using the images acquired with RVP-001 and those acquired with the GBCA.

For each reader, only matching lesion-pairs present in both MRI image sets (using GBCA and RVP-001) will be considered.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reveal Pharmaceuticals Inc.

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Vera Hoffman, Reveal Pharmaceuticals
  • Study Director: Srini Mukundan, M.D./PhD., Reveal Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Actual)

December 19, 2025

Study Completion (Actual)

December 19, 2025

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVL-102-23
  • 9R44CA261240-04A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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