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RecruitingAccepts healthy volunteersEarly Phase 1

Radiocaine Safety Study

Lutroo Imaging LLC · with Stanford University · NCT07081217

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
6
US sites recruiting
1
Study start
June 17, 2025
Record last updated
August 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Intravenous Radiocaine

Conditions: Healthy Subjects

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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
  • 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

Recruiting US locations

  • Stanford University School of Medicine

    Stanford, CA 94305

    Site contact: Clinical Associate Professor of Radiology · (650) 724-4421 · srj8@stanford.edu

Study contacts (from the official record)

  • Chief Medical Officer · 877-310-1326 · info@lutrooimaging.com
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Radiocaine Safety Study (NCT07081217) | Bored Studies