Radiocaine Safety Study for Healthy Volunteers

This study is testing the safety of Radiocaine, an investigational diagnostic test given through an IV (intravenous injection). Radiocaine is designed to help doctors see and measure activity in voltage-gated sodium channels, which are important for how cells work. This study is looking for 6 healthy adults, aged 18 and older, who are willing to have ECGs (heart tests), imaging scans, blood samples, and complete self-assessments. The main goals are to see how much radiation you absorb and to track any side effects for up to 30 days. This information will help guide future studies on Radiocaine.

Study design
This is a Phase 1, single-center, open-label study involving 6 healthy adult volunteers. It is not blinded, meaning both you and the study team will know you are receiving Radiocaine.
What's involved
You would receive a single IV injection of Radiocaine, undergo PET/MR imaging over several hours, and provide blood and urine samples at specific times. You will also have safety checks, including vital signs and lab tests, and complete self-assessment rating scales.
Compensation
Not stated in the trial record.
Follow-up
Your radiation absorbed dose will be measured at 1 day, and adverse events (side effects) will be monitored for 30 days after receiving Radiocaine.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07081217

Radiocaine Safety Study

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Lutroo Imaging LLC
~6 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Intravenous Radiocaine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiation absorbed dose/Effective dose
Measured over 1 day
+1 more outcome measured
Healthy Subjects
1 sites across 1 states
California1

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
  • Radiation absorbed dose/Effective dose1 day
  • Adverse events30 days

    Presence/absence of adverse events