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PET/MRI in the Diagnosis of Pediatric Chronic Pain

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04435821
Enrollment
5
Registered
2020-06-17
Start date
2020-11-19
Completion date
2024-10-31
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Neuropathic Pain, Nociceptive Pain, Pediatric Disorder

Keywords

PET/MRI, Pediatric Chronic Pain

Brief summary

\[18F\]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.

Detailed description

It is estimated that 20% to 35% of children and adolescents worldwide are affected by chronic pain. As a result of chronic pain, children may miss school, withdraw from social activities, and develop internalizing behaviors. Therefore, accurately identifying the cause of a child's pain is important for both proper treatment of the pain and to prevent problems secondary to the chronic pain. Evidence in the literature points strongly toward an involvement of the sigma-1 receptor in neurogenic inflammation, which is known to be an important pathophysiological mechanism for maintenance and perpetuation of chronic neuropathic pain. The investigators hope to image and identify activated pain pathways in pediatric pain paitents using a radiolabeled biomarker for increased S1R expression. By localizing and quantifying areas of increased S1R expression to sites of augmented nociceptive activity using hybrid molecular/anatomic imaging techniques, we will objectively identify sites of neurogenic inflammatory activity and pain generation. The ability to image the changes associated with chronic pain generating pathologies provides us with a tool to identify and measure the intensity of the pathology. Imaging S1R expression in chronic pain states in pediatric patients would be both novel in its application and extremely powerful in better characterizing pediatric pain.

Interventions

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

Sponsors

GE Healthcare
CollaboratorINDUSTRY
Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Pediatric Chronic Pain Patients

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients3 hoursBiodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026