Evaluation of Neuroinflammation in Children With Infantile Spasms

Overview

The purpose of this study was to investigate the presence of neuroinflammation in children with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its response to ACTH treatment by repeating the PK PET scan after treatment.

Full Title of Study: “Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2016

Interventions

  • Drug: ACTH
    • PK PET scan before and after ACTH treatment

Arms, Groups and Cohorts

  • Experimental: Infantile Spasms

Clinical Trial Outcome Measures

Primary Measures

  • Neuroinflammation in cortical and/or subcortical structures
    • Time Frame: up to 6 weeks
    • Neuroinflammation in cortical and/or subcortical structures of the brain in patients with Infantile Spasms will be evaluated with 11-C-PK11195 PET scan at the baseline and 2 weeks after the completion of ACTH treatment (given over 4 weeks), i.e., 6 weeks after the baseline PET scan.

Participating in This Clinical Trial

Inclusion Criteria

  • A clinical diagnosis of 'cryptogenic IS' – Normal MRI – No other neurological disorder Exclusion Criteria:
  • Abnormal MRI – No anti-inflammatory medication 48 hrs prior to PK PET scans – Parent/guardian unable to give written consent
  • Gender Eligibility: All

    Minimum Age: N/A

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Wayne State University
    • Provider of Information About this Clinical Study
      • Principal Investigator: Harry T Chugani, Professor – Wayne State University

    References

    Ajay Kumar, Vijay N. Tiwari, Otto Muzik, Pulak K. Chakraborty, Harry T Chugani. In-Vivo Measurement of Brain Inflammation with [11C]-[R]-PK-11195 Positron Emission Tomography in Children with Epileptic Disorders. Epilepsy Currents 2014;14:330 (abs)

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