Recruiting
Early Phase 1

Radiocaine™

Sponsor:

Lutroo Imaging LLC

Code:

NCT07081217

Conditions

Healthy Subjects

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Intravenous Radiocaine

Study Details

Brief summary:

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.

Conditions

Healthy Subjects

Study ID

NCT07081217

Start date

Jun 17, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy subjects

Interventions

Intravenous Radiocaine

Intravenous injection of Radiocaine

Primary outcome measure

  • Radiation absorbed dose/Effective dose [ Time Frame: 1 day ]
  • Adverse events [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Chief Medical Officer

877-310-1326info@lutrooimaging.com

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Clinical Associate Professor of Radiology

(650) 724-4421srj8@stanford.edu

More Information

Sponsor

Lutroo Imaging LLC

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Radiocaine
  • PET imaging
  • medical imaging
  • diagnostic imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lutroo Imaging LLC on 2026-08-27.