Radiocaine Safety Study

NCT07081217 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: LTR-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Radiocaine; PET imaging; medical imaging; diagnostic imaging

Outcome Measures

Primary Outcomes (2)

• Radiation absorbed dose/Effective dose

  1 day

• Adverse events

  Presence/absence of adverse events

  30 days

Other Outcomes (1)

• Biodistribution

  1 day

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Diagnostic Test: Intravenous Radiocaine

Interventions

Intravenous Radiocaine DIAGNOSTIC_TEST

Intravenous injection of Radiocaine

Healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lutroo Imaging LLC: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

Central Study Contacts

Chief Medical Officer

CONTACT

877-310-1326; info@lutrooimaging.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)