COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2024-08-15
Study Completion:2025-12-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06322342

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults of all sexes, aged 18-75 years
  2. 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. 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. 4. Acceptable renal function
  1. 1. Serious non-malignant disease that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor
  2. 2. Body mass index (BMI) greater than 35
  3. 3. Patients with clinically significant cardiac disease
  4. 4. MRI incompatibility

Contacts and Locations

Study Locations (Sites)

Yale New Haven Hospital
New Haven, Connecticut, 06510
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115
United States
University of Missouri
Columbia, Missouri, 65212
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Reveal Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-15
Study Completion Date2025-12-19

Study Record Updates

Study Start Date2024-08-15
Study Completion Date2025-12-19

Terms related to this study

Additional Relevant MeSH Terms

  • 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