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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 belowSelect...
I have been experiencing chronic pain for more than 2 months.
Select...
I have been experiencing chronic pain for more than 2 months.
Select...
My pain level is at least 4 out of 10.
Select...
I am 18 years old or older and experiencing pain.
Select...
My pain level is at least 4 out of 10.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English.
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
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.
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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
2,469 Previous Clinical Trials
17,501,557 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been experiencing chronic pain for more than 2 months.I have been experiencing chronic pain for more than 2 months.If you don't speak English, you cannot participate as a healthy volunteer.My pain level is at least 4 out of 10.I do not speak English.I am a healthy volunteer with a recent negative Covid test, regardless of vaccination status.I am 18 years old or older and experiencing pain.My pain level is at least 4 out of 10.I am a healthy volunteer experiencing pain.I am a healthy volunteer not on pain medication.You cannot participate if you are a healthy volunteer and cannot have an MRI.I am 18 years old or older.You cannot have an MRI scan because of the type of pain you have.If you feel very uncomfortable in small or enclosed spaces.If you are uncomfortable in small, enclosed spaces, you cannot participate as a healthy volunteer.I am a healthy volunteer and I am 18 years old or older.You need to have a negative Covid test within 72 hours of the scan, regardless of whether you have been vaccinated or not.If you're getting a scan and have pain, you need to have a negative Covid test within 3 days, no matter if you've been vaccinated or not.
Research Study Groups:
This trial has the following groups:- Group 1: Pain Patients
- Group 2: Healthy Volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Nociceptive Pain Patient Testimony for trial: Trial Name: NCT03556137 — Phase 1
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