[18F]Radiocaine: Radiation and Radiochemical Safety
Lutroo Imaging LLC
Summary
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels in pain-related peripheral nerves. The study will enroll healthy adult volunteers and aims to inform future clinical development in pain imaging. Radiocaine™ is being developed as a potential imaging biomarker for the localization and quantification of pain.
Description
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind to voltage-gated sodium channels expressed in peripheral nerves. The study will enroll six healthy adult volunteers, each of whom will receive a single intravenous dose of Radiocaine™. Serial PET/MR imaging will be performed over several hours post-injection to assess the distribution of the radiotracer in various tissues and organs. Blood and urine samples will be collected at predefined time…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Pain-free * Unremarkable baseline health without report of chronic or acute pain Exclusion Criteria: * Physical pain of almost any severity
Interventions
- Diagnostic TestIntravenous Radiocaine
Intravenous injection of Radiocaine
Location
- Stanford University School of MedicineStanford, California