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RECRUITING Early Phase 1

Radiocaine Safety Study In Healthy Human Subjects

NCT07081217 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST Intravenous Radiocaine

Study Locations (1)

California

  • Stanford University School of Medicine — Stanford

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2025-06-17
Est. Completion 2026-04
Phase Early Phase 1

Sponsor

Lutroo Imaging

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07081217

The ClinicalTrials.gov registry entry for NCT07081217 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lutroo Imaging, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention — of which Intravenous Radiocaine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07081217 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07081217 about?

NCT07081217 is a clinical study titled "Radiocaine Safety Study In Healthy Human Subjects". 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 ad...

What is the current status of trial NCT07081217?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2025-06-17. Estimated completion is 2026-04.

What conditions does trial NCT07081217 study?

This clinical trial studies the following conditions: Healthy Subjects. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07081217?

The interventions under investigation include: Intravenous Radiocaine (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07081217?

This trial is sponsored by Lutroo Imaging, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07081217 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial