Central Nervous System (CNS) LesionsPhase 2NCT06322342
Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent
A Phase 2 study testing RVP-001 in people with Central Nervous System (CNS) Lesions and Brain Metastases, run by Reveal Pharmaceuticals Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Central Nervous System (CNS) Lesions, Brain Metastases, Brain Neoplasms
- What is being tested?
- RVP-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Aug 2024to 19 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital
Boston, Massachusetts, 02115
University of Missouri
Columbia, Missouri, 65212
Duke University Medical Center
Durham, North Carolina, 27710
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
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
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.
Read the detailed description
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.
- Conditions
- Central Nervous System (CNS) Lesions, Brain Metastases, Brain Neoplasms, Brain Neoplasms, Benign, Brain Tumor, Primary, Brain Tumor, Recurrent
- Being tested
- RVP-001
- Medical subject headings
- Brain Neoplasms, Multiple Sclerosis, Neurofibroma, Neuroma, Acoustic, Central Nervous System Neoplasms, Meningioma, Glioma, Neurilemmoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVP-001Drug
Also called Mn-PyC3A, mangaverate
MRI contrast agent
| Study group | Role | What they receive |
|---|---|---|
| 2 mg/Mn/kg | Experimental | 6 subjects each will receive RVP-001 at a dose of 2 mg Mn/kg Receives: Drug: RVP-001 |
| 7 mg/Mn/kg | Experimental | 6 subjects each will receive RVP-001 at a dose of 7 mg Mn/kg Receives: Drug: RVP-001 |
| 12 mg/Mn/kg | Experimental | 6 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg Receives: Drug: RVP-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Treatment-emergent adverse events for each dose level will be summarized.
Measured: From time of dosing to 7 days post dose
Lesion visualization criteria for RVP-001 enhanced MRI compared to unenhanced MRI
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.
Measured: 1 day
Lesion visualization criteria for RVP-001 compared to gadolinium-based contrast agent (GBCA)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start15 Aug 2024
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System (CNS) LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reveal Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322342
- Sponsor's protocol ID
- RVL-102-23
- Other IDs
- 9R44CA261240-04A1
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06322342
- Acronym / sponsor ID
- RVL-102-23
- Conditions
- Central Nervous System (CNS) Lesions, Brain Metastases, Brain Neoplasms, Brain Neoplasms, Benign, Brain Tumor, Primary, Brain Tumor, Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Reveal Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 mg/Mn/kg | Experimental | Drug: RVP-0016 subjects each will receive RVP-001 at a dose of 2 mg Mn/kg |
| 7 mg/Mn/kg | Experimental | Drug: RVP-0016 subjects each will receive RVP-001 at a dose of 7 mg Mn/kg |
| 12 mg/Mn/kg | Experimental | Drug: RVP-0016 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVP-001Also: Mn-PyC3A, mangaverateMRI contrast agent | Drug | 12 mg/Mn/kg, 2 mg/Mn/kg, 7 mg/Mn/kg |
Primary outcome
Adverse Events
Time frame: From time of dosing to 7 days post dose
Treatment-emergent adverse events for each dose level will be summarized.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVP-001 in people with Central Nervous System (CNS) Lesions and Brain Metastases, run by Reveal Pharmaceuticals Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From time of dosing to 7 days post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.