PET/MRI in the Diagnosis of Pediatric Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04435821
• Other study ID #: 52830
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: November 19, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia
• Neuropathic Pain
• Nociceptive Pain
• Pediatric Disorder

Intervention

Drug:
• [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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients	Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.	3 hours