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

NCT06322342 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-26

No results posted yet for this study

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

  • 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
  • Neoplasia

Interventions

DRUG

RVP-001

MRI contrast agent

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Reveal Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2025-12-19
Completion
2025-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06322342 on ClinicalTrials.gov