18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness

April 19, 2018 updated by: Jing Zhao, Guangzhou General Hospital of Guangzhou Military Command
Clinical examinations are difficult to discriminate between vegetative state and minimally conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not been established in a clinical setting. we will do a forward study of PET imaging in disorders of consciousness patients, and validate with clinical assessments with the coma recovery Scale-Revised(CRS-R).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Every patient need to be conducted the PET/CT scanning two times.The first time is resting state.The second time is stimulated state by watching a vedio.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The PET/CT Centre Guangzhou General Hospital of Guangzhou Military Command

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of disorder of consciousness

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Controls
The controls are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the controls sleep for an hour in a quiet room before scanning.
EXPERIMENTAL: Patients
The patients are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the patients sleep for an hour in a quiet room before scanning.
Radiation: 18F-FDG
18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
standardized uptake value
Time Frame: 60 mins after injecting 18F-FDG
60 mins after injecting 18F-FDG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

Investigators

  • Study Director: Yin Jilin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 5, 2017

Study Registration Dates

First Submitted

March 25, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (ESTIMATE)

December 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYXK0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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