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

Description

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

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Central Nervous System (CNS) Lesions
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06510

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Brigham & Women's Hospital, Boston, Massachusetts, United States, 02115

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Reveal Pharmaceuticals Inc.,

Study Record Dates

2025-12