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The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
18F-FDG
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring 18F-FDG

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Forty subjects with a diagnosis of PD whom must:

    i.Male or female patients, age range 20~80. ii.Patients should be fulfilled Criteria of diagnosis of Parkinson disease8 of "possible" or "probable" PD (Appendix I).

    iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  2. Forty subjects with a diagnosis of MSA whom must:

    i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Consensus diagnostic criteria of "possible" or "probable" MSA14 (Appendix II).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  3. Twenty subjects with a diagnosis of PSP whom must:

    i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the NINDS-SPSP clinical criteria for the diagnosis of PSP of "possible" or "probable" PSP35 (Appendix III).

    iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  4. Twenty subjects with a diagnosis of CBD whom must:

    i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Kumar's criteria of CBD36 (Appendix IV). iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

Exclusion Criteria:

  1. Pregnant or becoming pregnant during the study or current breast feeding.
  2. Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.

    i.Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances.

    ii.Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease.

  3. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
  4. History or presence of QTc prolongation.
  5. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
  6. Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus, multiple infarction and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed.
  7. Patients who have the evidence of secondary parkinsonism (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases, such as spinocerebellar atrophy (SCA), Wilson's disease, hydrocephalus, multiple infarction, serious head injury and definite history of neurotoxin exposure, are excluded.
  8. General PET exclusion criteria.

Sites / Locations

  • Chang Gung Memory Hpspital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DTBZ for Parkinson's Disease

Arm Description

This study will compare the brain uptake of 18F- DTBZ in 40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP . Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Outcomes

Primary Outcome Measures

To analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD ,PSP,MSA,CBD.
All subjects that received 18F-FP-(+)-DTBZ for injection.Sensitivity and specificity analysis of VMAT2 imaging will include all subjects for whom there is sufficient data to evaluate the parameter in question.Descriptive statistics will be presented to help detect changes within groups or differences between groups (PD vs. MSA, CBD, PSP). The descriptive statistics will include mean, standard deviation, median, and ranges for continuous variables, and frequency and percent frequency for categorical variables.Mann Whitney test will be used to compare the mean SUVR values between PD and other groups. ROC curve will be used to determinate the diagnostic threshold of SUVR and the sensitivity and specificity of 18F- DTBZ PET in the differentiating PD, MSA, PSP, and CBD. Statistical analysis was performed using a unpaired t test based on one contrast to test a hypothesis of regional abnormal uptakes of 18F-DTBZ in an individual MSA/PSP/CBD patient compared to a PD group.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2013
Last Updated
November 10, 2013
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01824056
Brief Title
The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography
Official Title
The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography With Vesicular Monoamine Transporter Ligand (18F-DTBZ)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders, including multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive supranuclear palsy (PSP).
Detailed Description
40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP, will be enrolled. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit. Safety measurement will be evaluated by medical history, vital signs, physical examinations,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
18F-FDG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-DTBZ for Parkinson's Disease
Arm Type
Experimental
Arm Description
This study will compare the brain uptake of 18F- DTBZ in 40 patients with PD, 40 patients with MSA, 20 patients with CBD, and 20 patients with PSP . Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Intervention Description
During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging. The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.
Primary Outcome Measure Information:
Title
To analyze the sensitivity and specificity of 18F-DTBZ PET to the differential diagnosis of PD ,PSP,MSA,CBD.
Description
All subjects that received 18F-FP-(+)-DTBZ for injection.Sensitivity and specificity analysis of VMAT2 imaging will include all subjects for whom there is sufficient data to evaluate the parameter in question.Descriptive statistics will be presented to help detect changes within groups or differences between groups (PD vs. MSA, CBD, PSP). The descriptive statistics will include mean, standard deviation, median, and ranges for continuous variables, and frequency and percent frequency for categorical variables.Mann Whitney test will be used to compare the mean SUVR values between PD and other groups. ROC curve will be used to determinate the diagnostic threshold of SUVR and the sensitivity and specificity of 18F- DTBZ PET in the differentiating PD, MSA, PSP, and CBD. Statistical analysis was performed using a unpaired t test based on one contrast to test a hypothesis of regional abnormal uptakes of 18F-DTBZ in an individual MSA/PSP/CBD patient compared to a PD group.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Forty subjects with a diagnosis of PD whom must: i.Male or female patients, age range 20~80. ii.Patients should be fulfilled Criteria of diagnosis of Parkinson disease8 of "possible" or "probable" PD (Appendix I). iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent). Forty subjects with a diagnosis of MSA whom must: i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Consensus diagnostic criteria of "possible" or "probable" MSA14 (Appendix II). iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent). Twenty subjects with a diagnosis of PSP whom must: i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the NINDS-SPSP clinical criteria for the diagnosis of PSP of "possible" or "probable" PSP35 (Appendix III). iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent). Twenty subjects with a diagnosis of CBD whom must: i.Male or female patients, age range 20~80. ii.Patients should be fulfilled the Kumar's criteria of CBD36 (Appendix IV). iii.Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent). Exclusion Criteria: Pregnant or becoming pregnant during the study or current breast feeding. Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness. i.Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances. ii.Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse. History or presence of QTc prolongation. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation. Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus, multiple infarction and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed. Patients who have the evidence of secondary parkinsonism (multiple infarcts, intoxication, and hydrocephalus, etc) or other neurodegenerative diseases, such as spinocerebellar atrophy (SCA), Wilson's disease, hydrocephalus, multiple infarction, serious head injury and definite history of neurotoxin exposure, are excluded. General PET exclusion criteria.
Facility Information:
Facility Name
Chang Gung Memory Hpspital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography

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