Radiocaine safety and whole-body PET imaging in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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
* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.