MedDataX Logo

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

NCT ID: NCT06322342

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasia 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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2 mg/Mn/kg

6 subjects each will receive RVP-001 at a dose of 2 mg Mn/kg

Group Type EXPERIMENTAL

RVP-001

Intervention Type DRUG

MRI contrast agent

7 mg/Mn/kg

6 subjects each will receive RVP-001 at a dose of 7 mg Mn/kg

Group Type EXPERIMENTAL

RVP-001

Intervention Type DRUG

MRI contrast agent

12 mg/Mn/kg

6 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg

Group Type EXPERIMENTAL

RVP-001

Intervention Type DRUG

MRI contrast agent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RVP-001

MRI contrast agent

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mn-PyC3A mangaverate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Reveal Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

University of Missouri

Columbia, Missouri, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9R44CA261240-04A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RVL-102-23

Identifier Type: -

Identifier Source: org_study_id