RVP-001 for Brain Tumors

Recruiting at 4 trial locations

Overseen By Skye Sully

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Reveal Pharmaceuticals Inc.

Must not be taking: Linear GBCA

Disqualifiers: Cardiac disease, MRI incompatibility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests RVP-001, a new MRI contrast agent, to determine its safety and effectiveness for individuals with brain-related conditions like tumors or multiple sclerosis. The study compares RVP-001's performance to that of commonly used gadolinium-based agents. Participants will receive one dose of RVP-001 and undergo MRI scans to evaluate its effectiveness. Ideal candidates have brain lesions and have recently undergone a gadolinium-enhanced MRI showing specific brain changes. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRI contrast agent is safe for use in humans?

Research has shown that RVP-001, a new MRI contrast agent made with manganese, might be safer than traditional gadolinium-based agents. This is significant because some individuals experience adverse reactions to gadolinium. Early studies suggest that RVP-001 avoids some of these harmful effects.

Participants in earlier studies generally tolerated RVP-001 well, with no major safety issues reported. These results are encouraging, especially since the participants had conditions like brain tumors or multiple sclerosis, which can increase sensitivity to side effects.

This trial is in phase 2, indicating that the treatment has already passed initial safety tests. The current phase focuses on further assessing its safety and effectiveness in a larger group. This helps researchers confirm that the treatment can be safely used in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about RVP-001 for brain tumors because it offers a new mechanism of action by targeting manganese pathways, which is different from the current standard treatments like surgery, radiation, and chemotherapy. Unlike these existing options, RVP-001 is designed to exploit the metabolic vulnerabilities of tumor cells. This innovative approach could potentially improve treatment outcomes and reduce side effects associated with traditional therapies.

What evidence suggests that this MRI contrast agent is effective for brain tumors?

Research has shown that RVP-001 is a promising new MRI contrast agent for people with brain tumors. Unlike traditional agents that use gadolinium, RVP-001 uses manganese, which might be safer for some patients. Early findings suggest that RVP-001 can improve MRI images, making brain lesions easier to see. This improvement could help doctors better diagnose and monitor brain conditions. Although more information is needed to confirm these results, the early evidence is encouraging. ^{1 2 6 7 8}

Who Is on the Research Team?

Vera Hoffman

Principal Investigator

Reveal Pharmaceuticals

Srini Mukundan, M.D./PhD.

Principal Investigator

Reveal Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with brain tumors, who've had a recent MRI showing at least one lesion of minimum 5mm. They must have good kidney function and be able to follow up with MRIs. It's not for those with serious non-cancer diseases, certain heart conditions, or who've used specific contrast agents in their MRI.

Inclusion Criteria

I've had an MRI showing a brain lesion larger than 5mm.

My kidney function is within normal ranges.

I am under MRI surveillance for my brain lesions and can have an MRI every six weeks after taking RVP-001.

Exclusion Criteria

MRI incompatibility

I do not have a serious illness that could interfere with the study.

I have received a specific contrast agent for an MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Imaging

Baseline unenhanced MRI scan performed prior to RVP-001 injection

1 day

1 visit (in-person)

Treatment

Single dose of RVP-001 administered with dynamic and steady state imaging

1 day

1 visit (in-person)

Follow-up

Unenhanced MRI scan follow-up study performed between one week and six weeks following RVP-001 administration

1-6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RVP-001

Trial Overview The study tests RVP-001 given as a single IV shot at three increasing doses. It aims to see how safe it is and how well it works in people with brain lesions that show up on MRIs using gadolinium-based contrast.

How Is the Trial Designed?

Group I: 7 mg/Mn/kg Experimental Treatment 1 Intervention

6 subjects each will receive RVP-001 at a dose of 7 mg Mn/kg

Group II: 2 mg/Mn/kg Experimental Treatment 1 Intervention

6 subjects each will receive RVP-001 at a dose of 2 mg Mn/kg

Group III: 12 mg/Mn/kg Experimental Treatment 1 Intervention

6 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg

Who Is Running the Clinical Trial?

Reveal Pharmaceuticals Inc.

Lead Sponsor

Trials

2

Recruited

60+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06322342

Phase 2 Ascending Dose Safety and Efficacy Study of RVP ... 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 ...

2. trials.braintumor.org trials.braintumor.org/trials/NCT06322342

Phase 2 Ascending Dose Safety and Efficacy Study of RVP ... 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 ...

3. bwh.trialstoday.org bwh.trialstoday.org/trial/NCT06322342

Phase 2 Ascending Dose Safety and Efficacy Study of RVP ... 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 ...

4. reporter.nih.gov reporter.nih.gov/project-details/10861085

Manganese Based MRI Contrast Agent The goal of this proposal is to test the safety and imaging efficacy of this new agent RVP-001 in patients with brain cancer or other brain disorders. NIH ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03417

Phase 2 Ascending Dose Safety and Efficacy Study of RVP ... 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 ...

6. massgeneral.org massgeneral.org/news/press-release/novel-mri-contrast-agent-sidesteps-toxic-effects-of-current-products

Novel MRI contrast agent sidesteps toxic effects of current ... Study Identifies Signs of Repeated Blast-Related Brain Injury in Active-Duty United States Special Operations Forces.

7. trialx.com trialx.com/clinical-trials/listings/288132/phase-2-ascending-dose-safety-and-efficacy-study-of-rvp-001-a-manganese-based-mri-contrast-agent/

Phase 2 Ascending Dose Safety and Efficacy Study of RVP ... This Phase 2 trial will assess the safety, tolerability, efficacy, imaging pharmacodynamics, and pharmacokinetics of RVP-001, a novel manganese- ...

8. drugtargetreview.com drugtargetreview.com/news/27506/mn-pyc3a-mri/

Mn-PyC3A MRI contrast agent may be safer alternative to ... Mn-PyC3A MRI contrast agent may be a safer alternative to gadolinium, Mn-PyC3A produced contrast enhancement of blood vessels.