Radiocaine Safety Study In Healthy Human Subjects

NCT ID: NCT07081217

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2026-04-30

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 in pain-related peripheral nerves. The study will enroll healthy adult volunteers and aims to inform future clinical development in pain imaging. Radiocaine™ is being developed as a potential imaging biomarker for the localization and quantification of pain.

Detailed Description

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 to voltage-gated sodium channels expressed in peripheral nerves.

The study will enroll six healthy adult volunteers, each of whom will receive a single intravenous dose of Radiocaine™. Serial PET/MR imaging will be performed over several hours post-injection to assess the distribution of the radiotracer in various tissues and organs. Blood and urine samples will be collected at predefined timepoints to support pharmacokinetic and dosimetry modeling. Safety assessments-including vital signs, laboratory tests, and monitoring for adverse events-will be conducted throughout the study.

The primary objectives are to:

• Evaluate the safety and tolerability of a single dose of Radiocaine™ in healthy individuals;
• Characterize the biodistribution of Radiocaine™ in key organs and tissues;
• Estimate radiation exposure (dosimetry) to inform future clinical use.

These data will guide dosing, image acquisition timing, and safety thresholds for upcoming studies in patients with chronic or neuropathic pain. The results will also support the further development of Radiocaine™ as a potential molecular imaging biomarker for the localization and quantification of pain in human subjects.

This study is intended for early-stage characterization of Radiocaine™ in preparation for future clinical studies involving patients.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy subjects

Group Type: EXPERIMENTAL

Intravenous Radiocaine

Intervention Type: DIAGNOSTIC_TEST

Intravenous injection of Radiocaine

Interventions

Intravenous Radiocaine

Intravenous injection of Radiocaine

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Pain-free
• Unremarkable baseline health without report of chronic or acute pain

Exclusion Criteria

• Physical pain of almost any severity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Lutroo Imaging LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University School of Medicine

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chief Medical Officer

Role: CONTACT

info@lutrooimaging.com

877-310-1326

Facility Contacts

Clinical Associate Professor of Radiology

Role: primary

srj8@stanford.edu

(650) 724-4421

Other Identifiers

LTR-001

Identifier Type: -

Identifier Source: org_study_id