Radiocaine for Healthy Volunteers

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Lutroo Imaging LLC

Disqualifiers: Physical pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new imaging tool called Radiocaine™, which identifies pain in the body by highlighting specific nerve channels. The goal is to assess its safety and track its movement through the body. This tool could help doctors better understand and locate pain in the future. Healthy individuals without ongoing or recent pain are suitable candidates for this trial. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this innovative tool functions in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Since the study is for healthy volunteers without pain, it might not require changes to your current medications, but it's best to check with the trial organizers.

What prior data suggests that Radiocaine is safe for healthy volunteers?

Research shows that Radiocaine is being tested in healthy volunteers to assess its safety. This early Phase 1 trial marks one of the first times the treatment is studied in people. At this stage, researchers focus on how well people tolerate the treatment and identify any possible side effects.

Specific data from these early tests is not yet available, so clear evidence of its safety in humans is lacking. However, the FDA's oversight of the study indicates that earlier tests in animals or labs were promising enough to warrant human trials. This trial aims to determine if Radiocaine is safe and if there are any negative effects when used as a tool to image pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Radiocaine is unique because it combines a novel anesthetic approach with radioisotope technology, potentially offering a more precise way to manage pain. Unlike standard anesthetics that typically require systemic administration, Radiocaine's innovative delivery method could target specific areas with minimal side effects. Researchers are excited about its potential to revolutionize how localized pain is managed, possibly providing faster relief and reducing the need for higher doses of traditional anesthetics.

What evidence suggests that Radiocaine is effective for pain imaging?

Research has shown that Radiocaine™ is a promising new tool for identifying and measuring pain in the body. It attaches to specific nerve areas crucial for pain sensation. Although still in early development, this trial studies Radiocaine™ with healthy volunteers to ensure its safety and understand its function in the body. These initial studies will guide future research in individuals with chronic or nerve-related pain. Radiocaine™ has the potential to help doctors better understand and treat pain by enabling visualization through PET scans. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to participate in a study evaluating Radiocaine™, a new imaging agent. Participants should be willing to undergo PET scans and have no history of allergic reactions to similar compounds.

Inclusion Criteria

I do not suffer from ongoing or sudden pain.

I do not experience pain.

Exclusion Criteria

I experience physical pain of any level.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single intravenous dose of Radiocaine™ followed by serial PET/MR imaging over several hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event monitoring

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Radiocaine

Trial Overview The trial tests the safety of Radiocaine™, an investigational drug that binds to nerve channels involved in pain. It's given through the veins and tracked with PET scans to see how it spreads and leaves the body.

How Is the Trial Designed?

Group I: Healthy subjects Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Lutroo Imaging LLC

Lead Sponsor

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07081217

Radiocaine Safety Study In Healthy Human Subjects These data will guide dosing, image acquisition timing, and safety thresholds for upcoming studies in patients with chronic or neuropathic pain. The results ...

2. withpower.com withpower.com/trial/early-phase-1-healthy-subjects-hs-5-2025-99aff

Radiocaine for Healthy Volunteers This trial is for healthy adults who want to participate in a study evaluating Radiocaine™, a new imaging agent. Participants should be willing to undergo PET ...

3. reporter.nih.gov reporter.nih.gov/search/10EECF0E478EC6D37598B8961CAA4A01A2FFCEB861BF/project-details/10794862

norwood, braxton The proposed study will evaluate Radiocaine in early-stage clinical trials. Successful results will set the stage for applied clinical trials that further ...

4. patlynk.com patlynk.com/trial/NCT07081217

Radiocaine Safety and Dosimetry in Healthy Volunteers 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 ...

5. synapse.patsnap.com synapse.patsnap.com/article/lutroo-imaging-starts-phase-1-trial-of-radiocaine-for-pain-imaging

Lutroo Imaging Starts Phase 1 Trial of Radiocaine™ for ... The Phase 1 trial is a single-center, open-label study enrolling healthy volunteers. Its primary objectives include evaluating the safety ...

6. trialx.com trialx.com/clinical-trials/listings/324637/radiocaine-safety-study-in-healthy-human-subjects/

Radiocaine Safety Study In Healthy Human Subjects These data will guide dosing, image acquisition timing, and safety thresholds for upcoming studies in patients with chronic or neuropathic pain.

7. lutrooimaging.com lutrooimaging.com/lutroo-imaging-begins-phase-1-clinical-trial-of-radiocaine

Lutroo Imaging Begins Phase 1 Clinical Trial of Radiocaine This first-in-human PET imaging study is a single-center, open-label trial enrolling healthy volunteers. The trial's primary goals include ...

8. braxtonnorwood.com braxtonnorwood.com/lutroo-imaging-launches-radiocaine-clinical-trial/

Lutroo Imaging Launches First-in-Human Study of Radiocaine ... The trial is being conducted under FDA IND clearance and focuses on evaluating safety, biodistribution, and radiation dosimetry in healthy volunteers. Early ...