Radiocaine Safety Study

Part of paid clinical trials in Stanford, California.

Sponsor
Lutroo Imaging LLC
Study ID
NCT07081217
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Intravenous Radiocaine — DIAGNOSTIC_TEST
    Intravenous injection of Radiocaine

Study Details

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. The study enrolls adult volunteers and aims to inform future clinical development in molecular imaging applications. Radiocaine™ is being developed as a potential diagnostic imaging agent and imaging biomarker for the localization and quantification of sodium channel activity.

Key Dates

Start date
Jun 17, 2025
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy subjects

Primary Outcome Measure

Radiation absorbed dose/Effective dose [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305
Clinical Associate Professor of Radiology
(650) 724-4421

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