Recruiting

Radiocaine Safety and Dosimetry in Healthy Volunteers

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What is being tested

Intravenous Radiocaine

Diagnostic Test
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Early Phase 1
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorLutroo Imaging LLC
Study ContactChief Medical Officer
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: June 17, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on Radiocaine™, a new investigational PET radiotracer that targets sodium channels in peripheral nerves. The study aims to determine how safe this radiotracer is when given to healthy adults, as well as how it travels and behaves in the body. The findings will help develop Radiocaine™ as a potential tool for imaging pain in people with chronic or neuropathic pain. This early-stage research is crucial for setting the foundation for future studies involving patients and could lead to better understanding and management of pain. In the study, six healthy adult volunteers will receive a single dose of Radiocaine™ through an intravenous injection. Following the injection, participants will undergo PET/MR imaging over several hours to track where the radiotracer goes in their bodies. Blood and urine samples will also be collected at specific times to help understand how Radiocaine™ is processed by the body. Throughout the study, regular safety checks, including vital signs and lab tests, will be performed to monitor any side effects or adverse reactions. The results will provide valuable insights into the appropriate dosing and timing for future clinical applications.

Official Title[18F]Radiocaine: Radiation and Radiochemical Safety 
Principal SponsorLutroo Imaging LLC
Study ContactChief Medical Officer
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * Pain-free * Unremarkable baseline health without report of chronic or acute pain Exclusion Criteria: * Physical pain of almost any severity

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Stanford University School of Medicine

Stanford, United StatesSee the location
Recruiting
One Study Center