Radiocaine Safety Study
ConditionHealthy Subjects
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLutroo Imaging LLC
About this trial
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. The study enrolls adult volunteers and aims to inform future clinical development in molecular imaging applications. Radiocaine™ is being developed as a potential diagnostic imaging agent and imaging biomarker for the localization and quantification of sodium channel activity.
Eligibility criteria
Qualifiers
18 years and older
Able to provide written consent
Willing and able to undergo ECG, imaging, blood sampling, and complete self-assessment rating scales at the specified time points
Unremarkable baseline health without report of chronic or acute pain
Disqualifiers
Body mass index (BMI) of 32 or greater, weight >300 lbs
Diagnosis of severe depression/anxiety (PROMIS score > 95%) or suicidal ideation
History of opioid abuse or opioid use disorder
History of seizures or epilepsy
Trial design
Treatments tested in this trial
- Intravenous Radiocaine
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Lutroo Imaging LLC
Lead sponsor
Stanford University
Collaborator
Source ClinicalTrials.gov