Back to results18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness
Primary Purpose
Persistent Vegetative State
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-FDG
Sponsored by
About this trial
This is an interventional diagnostic trial for Persistent Vegetative State
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of disorder of consciousness
Exclusion Criteria:
-
Sites / Locations
- The PET/CT Centre Guangzhou General Hospital of Guangzhou Military Command
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Controls
Patients
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
standardized uptake value
Secondary Outcome Measures
Full Information
NCT ID
NCT02999490
First Posted
March 25, 2016
Last Updated
April 19, 2018
Sponsor
Guangzhou General Hospital of Guangzhou Military Command
1. Study Identification
Unique Protocol Identification Number
NCT02999490
Brief Title
18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness
Official Title
18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou General Hospital of Guangzhou Military Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Vegetative State
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controls
Arm Type
No Intervention
Arm Description
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.
Arm Title
Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
18F-FDG
Intervention Description
18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.
Primary Outcome Measure Information:
Title
standardized uptake value
Time Frame
60 mins after injecting 18F-FDG
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of disorder of consciousness
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin Jilin
Official's Role
Study Director
Facility Information:
Facility Name
The PET/CT Centre Guangzhou General Hospital of Guangzhou Military Command
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness
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