Evaluation of Neuroinflammation in Children With Infantile Spasms
Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 14, 2014
CompletedFirst Posted
Study publicly available on registry
March 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedNovember 7, 2017
November 1, 2017
3.3 years
March 14, 2014
November 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 6 weeks
Study Arms (1)
Infantile Spasms
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- A clinical diagnosis of 'cryptogenic IS'
- Normal MRI
- No other neurological disorder
You may not qualify if:
- Abnormal MRI
- No anti-inflammatory medication 48 hrs prior to PK PET scans
- Parent/guardian unable to give written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Related Publications (1)
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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 14, 2014
First Posted
March 20, 2014
Study Start
March 1, 2013
Primary Completion
July 1, 2016
Study Completion
July 1, 2017
Last Updated
November 7, 2017
Record last verified: 2017-11