PET/MRI in the Diagnosis of Pediatric Chronic Pain
Primary Purpose
Chronic Pain, Pediatric Disorder, Neuropathic Pain
Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]FTC-146
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Pain focused on measuring PET/MRI, Pediatric Chronic Pain
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).
Exclusion Criteria:
- MRI incompatible
- Pregnant or nursing
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pediatric Chronic Pain Patients
Arm Description
Individuals 11-18 years old, with chronic pain (lasting at least 2 months).
Outcomes
Primary Outcome Measures
[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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04435821
First Posted
June 15, 2020
Last Updated
March 8, 2023
Sponsor
Stanford University
Collaborators
GE Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT04435821
Brief Title
PET/MRI in the Diagnosis of Pediatric Chronic Pain
Official Title
Use of PET/MRI in the Diagnosis of Pediatric Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
GE Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pediatric Disorder, Neuropathic Pain, Nociceptive Pain
Keywords
PET/MRI, Pediatric Chronic Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Pediatric Chronic Pain Patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pediatric Chronic Pain Patients
Arm Type
Experimental
Arm Description
Individuals 11-18 years old, with chronic pain (lasting at least 2 months).
Intervention Type
Drug
Intervention Name(s)
[18F]FTC-146
Other Intervention Name(s)
S1R
Intervention Description
Participants will be injected with 0.08 mCi/kg [18F]FTC-146. A whole-body PET/MRI scan will be performed after injection.
Primary Outcome Measure Information:
Title
[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients
Description
Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen R Nadel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PET/MRI in the Diagnosis of Pediatric Chronic Pain
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