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NCT Number: NCT06322342

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

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.

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Key information

Conditions

Central Nervous System (CNS) Lesions Acoustic Neuroma Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Cancer Brain Diseases Brain Metastases Brain Neoplasm, Primary Brain Neoplasms Brain Neoplasms, Benign Brain Tumor Brain Tumor, Primary Brain Tumor, Recurrent Brain Tumors CNS Cancer CNS Lesion CNS Lymphoma CNS Metastases CNS Tumor Central Nervous System Diseases Central Nervous System Neoplasms Cranial Nerve Diseases Cranial Nerve Neoplasms Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Ear Diseases Glioma Immune System Diseases Inflammation Meningeal Neoplasms Meningioma Multiple Sclerosis Multiple Sclerosis Brain Lesion Neoplasia Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neuroinflammation Neuroinflammatory Diseases Neuroma Neuroma, Acoustic Neuromuscular Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Nervous System Neoplasms Retrocochlear Diseases Schwannomas Vestibulocochlear Nerve Diseases Von Hippel Lindau

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

RVP-001

Drug

MRI contrast agent

Other names: Mn-PyC3A, mangaverate

Primary outcomes

  1. Adverse Events

    Time frame: From time of dosing to 7 days post dose

    Treatment-emergent adverse events for each dose level will be summarized.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Reveal Pharmaceuticals Inc.

Industry

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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