Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322342
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-03-11
Brief Title:
Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001 a Manganese-based MRI Contrast Agent
Sponsor:
Reveal Pharmaceuticals Inc
Organization:
Reveal Pharmaceuticals Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 stable 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 be due to have a routine gadolinium-based contrast agent-enhanced MRI of the brain a few 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
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 be due to have a routine gadolinium-based contrast agent-enhanced MRI of the brain a few 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 will be pre-screened by study site personnel based on their upcoming appointment date for standard of care GBCA-enhanced MR imaging Subjects may include individuals who have a stable primary brain tumor metastatic brain tumors multiple sclerosis or other gadolinium-enhancing CNS lesions Screening to select subjects for study participation will occur at or around the time of the subjects scheduled appointment The appointment for standard of care imaging should take place at the designated study site
Following GBCA-enhanced MRI scan to confirm presence of target lesions 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 andor 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
Following GBCA-enhanced MRI scan to confirm presence of target lesions 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 9R44CA261240-04A1 | NIH | None | httpsreporternihgovquickSearch9R44CA261240-04A1 |