Recruiting

Radiocaine Safety and Dosimetry in Healthy Volunteers

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What is being tested

Intravenous Radiocaine

Diagnostic Test
Who is being recruted

Healthy Subjects

Over 18 Years
+3 Eligibility Criteria

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: July 23, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 17, 2025Actual 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: July 23, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy Subjects
Criteria
2 inclusion criteria required to participate
Pain-free
Unremarkable baseline health without report of chronic or acute pain
1 exclusion criteria prevent from participating
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

Presence/absence of adverse events

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 MedicineStanford, United StatesSee the location
Recruiting
One Study Center