Back to resultsEvaluation of Neuroinflammation in Children With Infantile Spasms
Primary Purpose
Infantile Spasms
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ACTH
Sponsored by
About this trial
This is an interventional diagnostic trial for Infantile Spasms focused on measuring Infantile Spasms, Neuroinflammation, PK11195, PET, ACTH
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infantile Spasms
Arm Description
Outcomes
Primary Outcome Measures
Neuroinflammation in cortical and/or subcortical structures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02092883
First Posted
March 14, 2014
Last Updated
November 3, 2017
Sponsor
Wayne State University
1. Study Identification
Unique Protocol Identification Number
NCT02092883
Brief Title
Evaluation of Neuroinflammation in Children With Infantile Spasms
Official Title
Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Spasms
Keywords
Infantile Spasms, Neuroinflammation, PK11195, PET, ACTH
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infantile Spasms
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ACTH
Intervention Description
PK PET scan before and after ACTH treatment
Primary Outcome Measure Information:
Title
Neuroinflammation in cortical and/or subcortical structures
Description
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.
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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)
Results Reference
background
Learn more about this trial
Evaluation of Neuroinflammation in Children With Infantile Spasms
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