Clinical trial

Use of [18F]FTC-146 PET/MRI in the Diagnosis of Chronic Pain

Name

45332

Description

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.

Trial arms

Trial start

2018-07-16

Estimated PCD

2024-12-31

Trial end

2024-12-31

Status

Recruiting

Phase

Early phase I

Treatment

[18F]FTC-146

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

Arms:

Healthy Volunteers, Pain Patients

Other names:

S1R

Size

190

Primary endpoint

[18F]FTC-146 Biodistribution in Healthy Volunteers

Estimated average of 3 hours

[18F]FTC-146 Biodistribution in Pain Patients

Estimated average of 3 hours

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 190, 'type': 'ESTIMATED'}}

Updated at

2023-07-20

1 organization

1 product

7 indications

Organization

Stanford University

Product

[18F]FTC-146

Indication

Neuropathic Pain

Indication