NCT07081217 · Lutroo Imaging LLC
Radiocaine Safety Study
What this study is about
This is a Phase 1, single-center, where both patients and doctors know the treatment given study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an experimental 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Stanford, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations