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

Launched by REVEAL PHARMACEUTICALS INC. · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new MRI contrast agent called RVP-001, which is made from manganese, to see how safe and effective it is for patients with certain brain conditions, such as brain tumors or multiple sclerosis. The aim is to find a safer alternative to the currently used gadolinium-based contrast agents, which can sometimes cause problems. In this study, participants will receive a single dose of RVP-001 before undergoing a routine MRI to compare how well it works against the traditional gadolinium-based agents.

To join this trial, participants must be adults aged 18 to 75 who have specific brain lesions that show up on MRI scans. They should have had a gadolinium-enhanced MRI within the last two weeks that showed at least one lesion that is 5 mm or larger. Participants will have regular check-ups and imaging to monitor their condition. If you or a loved one is interested, it’s important to discuss eligibility with a healthcare provider to see if this trial is a good fit.

Gender

ALL

Eligibility 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