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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up estimated average of 3 hours

Awards & highlights

Study Summary

This trial will compare how much of a certain drug collects in healthy people vs. people with chronic pain, in order to learn more about chronic pain.

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.Check my eligibility

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.See study design

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 a healthy volunteer with a recent negative Covid test, regardless of vaccination status.

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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.

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I am a healthy volunteer and I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated average of 3 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

[18F]FTC-146 Biodistribution in Healthy Volunteers

[18F]FTC-146 Biodistribution in Pain Patients

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.

0 / 8Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,387 Previous Clinical Trials

17,333,860 Total Patients Enrolled

1 Trials studying Nociceptive Pain

100 Patients Enrolled for Nociceptive Pain

GE HealthcareIndustry Sponsor

289 Previous Clinical Trials

630,866 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participation in this research study?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was initially published on July 16th 2018 and recently modified on October 31st 2022, is currently recruiting participants. In total, 190 people need to be recruited from a single research centre."

Answered by AI

How many participants are taking part in this trial?

"Affirmative. Clinicaltrials.gov reveals that this trial, which was initially posted on July 16th 2018 is presently recruiting participants. 190 patients are being sought out at a single site of the study's origin."

Answered by AI