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

NCT ID: NCT02999490

Last Updated: 2018-04-20

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

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-05

Brief Summary

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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

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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.

Conditions

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Persistent Vegetative State

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

18F-FDG

Intervention Type RADIATION

18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.

Interventions

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18F-FDG

18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of disorder of consciousness

Exclusion Criteria

\-
Minimum Eligible Age

10 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role lead

Responsible Party

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Jing Zhao

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yin Jilin

Role: STUDY_DIRECTOR

Locations

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The PET/CT Centre Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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HYXK0001

Identifier Type: -

Identifier Source: org_study_id

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