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
This trial accepts healthy volunteersQualifiers
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
Willing and able to participate in all imaging procedures and complete the self-assessment rating scales at the specified time points
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
Design model
Single group
Treatments tested in this trial
Intravenous Radiocaine
Diagnostic testIntravenous injection of Radiocaine
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Healthy subjectsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Radiation absorbed dose/Effective dose
Time frame
1 day2
Adverse events
Presence/absence of adverse events
Time frame
30 daysOther outcomes
1
Biodistribution
Biodistribution of Radiocaine
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Lutroo Imaging LLC
Lead sponsor
Stanford University
Collaborator
Source ClinicalTrials.gov