Testing a new manganese-based MRI contrast agent for brain lesions
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
This study is testing a new MRI contrast agent made from manganese to see if it can safely and effectively improve imaging of brain lesions in patients with conditions like brain tumors and multiple sclerosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Reveal Pharmaceuticals Inc. Industry-sponsored |
| Locations | 4 sites (New Haven, Connecticut and 3 other locations) |
| Trial ID | NCT06322342 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial evaluates RVP-001, a manganese-based MRI contrast agent, in patients with gadolinium-enhancing central nervous system lesions such as brain tumors and multiple sclerosis. The study aims to assess the safety, efficacy, and pharmacokinetics of RVP-001 at three different dose levels, comparing its imaging capabilities to traditional gadolinium-based contrast agents. Participants will undergo a series of MRI scans before and after receiving RVP-001 to monitor its effectiveness in enhancing visualization of lesions. The ultimate goal is to develop a gadolinium-free alternative for MRI imaging.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with known gadolinium-enhancing CNS lesions who have undergone a recent GBCA-enhanced MRI.
Not a fit: Patients with serious non-malignant diseases, significant cardiac issues, or MRI incompatibility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer, gadolinium-free option for MRI contrast that enhances imaging of brain lesions.
How similar studies have performed: While this approach is novel, previous studies have shown promise in developing alternative MRI contrast agents.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: 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
Where this trial is running
New Haven, Connecticut and 3 other locations
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham & Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Skye Sully
- Email: clinicaltrials@revealpharma.com
- Phone: (617) 398-0781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.