RECRUITING

Radiocaine Safety Study In Healthy Human Subjects

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

[18F]Radiocaine: Radiation and Radiochemical Safety

Quick Facts

Study Start:2025-06-17
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07081217

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pain-free
  2. * Unremarkable baseline health without report of chronic or acute pain
  1. * Physical pain of almost any severity

Contacts and Locations

Study Contact

Chief Medical Officer
CONTACT
877-310-1326
info@lutrooimaging.com

Study Locations (Sites)

Stanford University School of Medicine
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Lutroo Imaging LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-17
Study Completion Date2026-04

Study Record Updates

Study Start Date2025-06-17
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Radiocaine
  • PET imaging

Additional Relevant MeSH Terms

  • Healthy Subjects