Radiocaine safety and whole-body PET imaging in healthy adults
[18F]Radiocaine: Radiation and Radiochemical Safety
This early trial will test a single injection of Radiocaine, a fluorine-18 PET tracer that binds sodium channels, in healthy adult volunteers to see if it is safe and how it distributes in the body.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lutroo Imaging LLC Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT07081217 on ClinicalTrials.gov |
What this trial studies
This single-center, open-label Phase 1 study will enroll six healthy adult volunteers who each receive one intravenous dose of Radiocaine. Participants will undergo serial PET/MR imaging over several hours after injection while blood and urine samples are collected for pharmacokinetic and dosimetry modeling. Safety monitoring will include vital signs, laboratory tests, ECGs, and adverse event tracking. The data will inform dosing, image timing, and radiation exposure estimates to guide future clinical studies of Radiocaine as a molecular imaging biomarker.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 or older who can give informed consent, meet BMI and medical criteria, and are willing to undergo PET/MR scans, blood and urine sampling, and study procedures.
Not a fit: People with a history of seizures, opioid abuse, major psychiatric disorders, significant cardiac arrhythmia, high BMI (≥32), or active chronic pain are unlikely to benefit from this healthy-volunteer imaging study.
Why it matters
Potential benefit: If successful, Radiocaine could become a new PET biomarker to locate and quantify sodium channel activity, aiding diagnosis and development of treatments for conditions like neuropathic pain, epilepsy, and cardiac channelopathies.
How similar studies have performed: This is an early, largely novel human application—sodium-channel PET tracers have shown promise preclinically, but human data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stanford, California
- Stanford University School of Medicine — Stanford, California, United States (Recruiting)
Study contacts
- Study coordinator: Chief Medical Officer
- Email: info@lutrooimaging.com
- Phone: 877-310-1326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.