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PET/MRI with [18F]FTC-146 for Chronic Pain

Phase 1
Recruiting
Led By Sandip Biswal, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months.
Pain Patients: Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months.
Must not have
Pain Patients: Non-English speaker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated average of 3 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a special imaging dye and advanced scans to find out where chronic pain is coming from in the body. It includes people with different types of chronic pain and healthy volunteers. The dye helps highlight pain-related areas in the scans, aiding in better diagnosis and treatment.

Who is the study for?
This trial is for adults over 18, both healthy and those with chronic pain lasting more than 2 months. Participants can be vaccinated or unvaccinated but must test negative for Covid within 72 hours of the scan. People who are pregnant, nursing, claustrophobic, non-English speakers, on pain medication (healthy volunteers), or incompatible with MRI cannot join.
What is being tested?
[18F]FTC-146 and PET/MRI technology are being tested to identify the source of chronic pain by comparing its uptake in healthy individuals versus those with chronic pain. The study aims to understand how sigma-1 receptors contribute to chronic pain conditions.
What are the potential side effects?
The side effects related to [18F]FTC-146 and PET/MRI scans aren't detailed here; however, typical risks may include discomfort at injection site for tracer administration and exposure to radiation from the imaging process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been experiencing chronic pain for more than 2 months.
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I have been experiencing chronic pain for more than 2 months.
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My pain level is at least 4 out of 10.
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I am 18 years old or older and experiencing pain.
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My pain level is at least 4 out of 10.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated average of 3 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated average of 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
[18F]FTC-146 Biodistribution in Healthy Volunteers
[18F]FTC-146 Biodistribution in Pain Patients

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pain PatientsExperimental Treatment1 Intervention
Individuals suffering from nociceptive pain, neuropathic pain, and mixed pain (pain that appears to be both nociceptive and neuropathic) and undergo a \[18F\]FTC-146 PET/MRI scan.
Group II: Healthy VolunteersExperimental Treatment1 Intervention
Individuals who do not have pain and undergo a \[18F\]FTC-146 PET/MRI scan.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,475 Previous Clinical Trials
17,501,273 Total Patients Enrolled
2 Trials studying Nociceptive Pain
300 Patients Enrolled for Nociceptive Pain
GE HealthcareIndustry Sponsor
297 Previous Clinical Trials
633,456 Total Patients Enrolled
1 Trials studying Nociceptive Pain
100 Patients Enrolled for Nociceptive Pain
Sandip Biswal, MDPrincipal InvestigatorStanford University Department of Radiology
4 Previous Clinical Trials
340 Total Patients Enrolled
2 Trials studying Nociceptive Pain
228 Patients Enrolled for Nociceptive Pain

Media Library

[18F]FTC-146 Clinical Trial Eligibility Overview. Trial Name: NCT03556137 — Phase 1
Nociceptive Pain Research Study Groups: Pain Patients, Healthy Volunteers
Nociceptive Pain Clinical Trial 2023: [18F]FTC-146 Highlights & Side Effects. Trial Name: NCT03556137 — Phase 1
[18F]FTC-146 2023 Treatment Timeline for Medical Study. Trial Name: NCT03556137 — Phase 1
Nociceptive Pain Patient Testimony for trial: Trial Name: NCT03556137 — Phase 1
~2 spots leftby Dec 2024