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_TESTIntravenous 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
- Chief Medical Officer877-310-1326
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 |
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