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

NCT06322342 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: RVL-102-239R44CA261240-04A1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Adverse Events

  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

  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)

  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

Study Arms (3)

2 mg/Mn/kg

EXPERIMENTAL

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

Drug: RVP-001

7 mg/Mn/kg

EXPERIMENTAL

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

Drug: RVP-001

12 mg/Mn/kg

EXPERIMENTAL

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

Drug: RVP-001

Interventions

RVP-001 DRUG

MRI contrast agent

Also known as: Mn-PyC3A, mangaverate

12 mg/Mn/kg; 2 mg/Mn/kg; 7 mg/Mn/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of all sexes, aged 18-75 years
• 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
• 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)
• Acceptable renal function

You may not qualify if:

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

Sponsors & Collaborators

• Reveal Pharmaceuticals Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Multiple Sclerosis; Neurofibroma; Neuroma, Acoustic; Central Nervous System Neoplasms; Meningioma; Glioma; Neurilemmoma; Neuroinflammatory Diseases; Neoplasms

Interventions

Mn-PyC3A

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Peripheral Nervous System Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neuroma; Cranial Nerve Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 21, 2024
• Study Start: August 15, 2024
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)