Radiocaine Safety Study
[18F]Radiocaine: Radiation and Radiochemical Safety
Lutroo Imaging LLC
6 participants
Jun 17, 2025
INTERVENTIONAL
Conditions
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. 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
Inclusion Criteria5
- 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
- Willing and able to participate in all imaging procedures and complete the self-assessment rating scales at the specified time points
Exclusion Criteria18
- 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
- History of major Axis I or Axis II psychiatric disorder that might, in the opinion of the investigator, make it difficult for the subject to complete all the procedures (e.g. obsessive-compulsive disorder, bipolar disorder, schizophrenia, or schizoaffective disorder)
- History of cardiac arrhythmia
- History of major orthopedic surgery within the last 12 months
- Recent history (previous 6 months) of sodium channel blocker use, including, but not limited to: carbamazepine, lamotrigine, lidocaine, phenytoin, propranolol, or valproate
- Any significant systemic illness or medical condition that could lead to difficulty complying with the study protocol
- Creatinine clearance (calculated using the Cockcroft-Gault formula or measured) < 60 mL/min or serum creatinine >1.5 x ULN
- QTcF >470 msec for females and QTcF >450 msec for males on screening ECG
- MRI-incompatible implants, large tattoos, previous shrapnel injury
- Pregnancy or lactating
- History of contact sport participation, such as football, hockey, or rugby
- Known claustrophobia related to MR or PET-MRI scanners
- Recent blood donation/draw of >1 unit (previous 4 weeks)
- History of hypersensitivity to local anesthetics of the amide type
- Family or personal history of familial malignant hyperthermia
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Interventions
Intravenous injection of Radiocaine
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07081217