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Evaluation of Neuroinflammation in Children With Infantile Spasms

NCT ID: NCT02092883

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infantile Spasms

Keywords

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Infantile Spasms Neuroinflammation PK11195 PET ACTH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Infantile Spasms

Group Type EXPERIMENTAL

ACTH

Intervention Type DRUG

PK PET scan before and after ACTH treatment

Interventions

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ACTH

PK PET scan before and after ACTH treatment

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Harry T Chugani

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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)

Reference Type BACKGROUND

Other Identifiers

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25QNC

Identifier Type: -

Identifier Source: org_study_id