Actively Recruiting
Radiocaine Safety Study
Led by Lutroo Imaging LLC · Updated on 2026-05-11
6
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
Sponsors
L
Lutroo Imaging LLC
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Radiocaine Safety Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford University School of Medicine
Stanford, California, United States, 94305
Actively Recruiting
Research Team
C
Chief Medical Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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