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PET/MRI in the Diagnosis of Pediatric Chronic Pain

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ClinicalTrials.gov Identifier: NCT04435821
Recruitment Status : Enrolling by invitation
First Posted : June 17, 2020
Last Update Posted : July 2, 2021
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Sandip Biswal, Stanford University

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Pediatric Disorder Neuropathic Pain Nociceptive Pain Drug: [18F]FTC-146 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pediatric Chronic Pain Patients
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of PET/MRI in the Diagnosis of Pediatric Chronic Pain
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Pediatric Chronic Pain Patients
Individuals 11-18 years old, with chronic pain (lasting at least 2 months).
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.
Other Name: S1R




Primary Outcome Measures :
  1. [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [ Time Frame: 3 hours ]
    Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435821


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
GE Healthcare
Investigators
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Principal Investigator: Sandip Biswal, MD Stanford University
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Responsible Party: Sandip Biswal, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT04435821    
Other Study ID Numbers: 52830
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandip Biswal, Stanford University:
PET/MRI
Pediatric Chronic Pain
Additional relevant MeSH terms:
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Neuralgia
Chronic Pain
Nociceptive Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases