Radiocaine Safety Study

Recruiting now · Early Phase 1

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT07081217

Run by

Lutroo Imaging LLC

People needed

6

Starts

2025-06-17

Expected to finish

2026-07-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Willing and able to participate in all imaging procedures and complete the self-assessment rating scales at the specified time points

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States (enrolling)

Full record on ClinicalTrials.gov

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