Clinical trial

Use of PET/MRI in the Diagnosis of Pediatric Chronic Pain

Name

52830

Description

\[18F\]FTC-146 is a sigma-1 receptor detector and is an experimental radiotracer. Several studies have implicated involvement of sigma-1 receptors in generation and perpetuation of chronic pain conditions, while others are investigating anti sigma-1 receptor drugs for treatment of chronic pain. Using \[18F\]-FTC-146 and PET/MRI, we hope to learn what is the best approach to identify the source of pain generation and characterize the disease in pediatric patients with chronic pain.

Trial arms

Trial start

2020-11-19

Estimated PCD

2024-12-31

Trial end

2024-12-31

Phase

Early phase I

Treatment

[18F]FTC-146

Participants will be injected with 0.08 mCi/kg \[18F\]FTC-146. A whole-body PET/MRI scan will be performed after injection.

Arms:

Pediatric Chronic Pain Patients

Other names:

S1R

Size

100

Primary endpoint

[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients

3 hours

Eligibility criteria

Inclusion Criteria: * 11-18 years old. * Chronic pain (nociceptive, neuropathic or mixed pain) lasting at least 2 months. * Pain level of at least 4/10 on a 0-10 Comparative Pain Scale (reported at time of screening). * 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: * MRI incompatible * Pregnant or nursing * Non-English speaker * Claustrophobic

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pediatric Chronic Pain Patients', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-03-10

1 organization

1 product

4 indications

Organization

Product

Indication

Indication

Indication

Indication