Recruiting
Phase 1

Chronic Pain

Sponsor:

Stanford University

Code:

NCT03556137

Conditions

Neuropathic Pain

Nociceptive Pain

Mixed Pain (Nociceptive and Neuropathic)

Spinal Pain

Radiculopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

[18F]FTC-146

Study Details

Brief summary:

Several studies have implicated involvement of sigma-1 receptors (SR1s) in the generation of chronic pain, while others are investigating anti SR1 drugs for treatment of chronic pain. Using \[18F\]-FTC-146 and positron emission tomography/magnetic resonance imaging (PET/MRI), the investigators hope to identify the source of pain generation in patients with chronic pain. The purpose of this study is to compare the uptake of \[18F\]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain.

Conditions

Neuropathic Pain

Nociceptive Pain

Mixed Pain (Nociceptive and Neuropathic)

Spinal Pain

Radiculopathy

Study ID

NCT03556137

Start date

Jul 16, 2018

Status verified date

Jul, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Healthy Volunteers:

1. At least 18 years old.
2. Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

Pain Patients:

1. At least 18 years old.
2. Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months.
3. Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.
4. Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

Exclusion Criteria:

Healthy Volunteers:

1. Pain
2. Pain Medication
3. MRI incompatible
4. Pregnant or nursing
5. Non-English speaker
6. Claustrophobic

Pain Patients:

1. MRI incompatible
2. Pregnant or nursing
3. Non-English speaker
4. Claustrophobic

Study Design

Enrollment

190 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Pain Patients

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.

experimental: Healthy Volunteers

Individuals who do not have pain and undergo a \[18F\]FTC-146 PET/MRI scan.

Interventions

[18F]FTC-146

Adult participants will be injected with 5-10 mCi of \[18F\]FTC-146 and undergo a PET/MRI scan.

Primary outcome measure

  • [18F]FTC-146 Biodistribution in Healthy Volunteers [ Time Frame: Estimated average of 3 hours ]
  • [18F]FTC-146 Biodistribution in Pain Patients [ Time Frame: Estimated average of 3 hours ]

Central Contacts and Locations

Central contacts

Anand Veeravagu, MD

(650) 498-6154anand.veeravagu@stanford.edu

Adrian Valladarez

adrian98@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Adrian Valladarez, BA

adrian98@stanford.edu

Principal Investigator:

Anand Veeravagu, MD

More Information

Sponsor

Stanford University

Last update posted

Jul 20, 2023

Last verified

Jul, 2023

Keywords

  • PET/MRI
  • Chronic Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2023-07-20.