Radiocaine Safety and Dosimetry in Healthy Volunteers
Intravenous Radiocaine
Diagnostic Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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