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Radiocaine Safety Study In Healthy Human Subjects
Sponsor: 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.
Official title: [18F]Radiocaine: Radiation and Radiochemical Safety
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2025-06-17
Completion Date
2026-04
Last Updated
2025-07-23
Healthy Volunteers
Yes
Conditions
Interventions
Intravenous Radiocaine
Intravenous injection of Radiocaine
Locations (1)
Stanford University School of Medicine
Stanford, California, United States