Clinical trial · Interventional
Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (24)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acoustic Neuroma | Vestibular Schwannoma | ALIAS | 0.90 |
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Metastases | — | UNRESOLVED | — |
| Brain Neoplasm, Primary | Primary Brain Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Brain Neoplasms, Benign | Benign Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
| Brain Tumor, Recurrent | Brain Neoplasm | CURATED_BROADER |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RVP-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 2 mg/Mn/kg
- description
- 6 subjects each will receive RVP-001 at a dose of 2 mg Mn/kg
- interventionNames
- Drug: RVP-001
- type
- EXPERIMENTAL
- label
- 7 mg/Mn/kg
- description
- 6 subjects each will receive RVP-001 at a dose of 7 mg Mn/kg
- interventionNames
- Drug: RVP-001
- type
- EXPERIMENTAL
- label
- 12 mg/Mn/kg
- description
- 6 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available