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A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.
The primary objective of this protocol is to assess the rate of change in striatal 18F-DTBZ uptake in a cohort of Parkinson's disease patients.
This study is expected to be completed in a period of 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DTBZ AV-133 | Experimental | 18F-DTBZ AV-133 imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DTBZ AV-133 | Drug | A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36 | To expand the database of 18F-DTBZ PET imaging in Parkinson's Disease patients to refine the definition of a positive scan in patient with PD. | three years |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients. | The test/retest reliability will be estimated from a subgroup of the study subjects (10 subjects) who receive additional scan within 4 weeks since baseline image. In order to refine the definition of a positive 18F-DTBZ in patient with PD as compared to healthy control, quantitative measurement will be used. The standard uptake value (SUV) of each brain regions will be calculated. The SUV is a widely used, simple PET quantifier, calculated as a ratio of tissue radioactivity concentration (e.g. in units kBq/ml) at time t, CPET(t) and injected dose (e.g. in units MBq) at the time of injection divided by body weight (e.g. in units kg).SUV = CPET(t) / (Injected dose / Patient's weight), t =90min, and the unit of SUV is g/ml. |
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Inclusion Criteria:
Exclusion criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 18F-DTBZ AV-133 | 18F-DTBZ AV-133 imaging 18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 18F-DTBZ AV-133 | 18F-DTBZ AV-133 imaging 18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36 | To expand the database of 18F-DTBZ PET imaging in Parkinson's Disease patients to refine the definition of a positive scan in patient with PD. | Posted | Mean | 80% Confidence Interval | SUVR | three years |
|
|
three yaers
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 18F-DTBZ AV-133 | 18F-DTBZ AV-133 imaging 18F-DTBZ AV-133: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. kun-Ju Lin | Chang Gung Memorial Hospital | 033281200 | 2632 | lin4857@adm.cgmh.org.tw |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C549477 | florbenazine F 18 |
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| three years |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients. | The test/retest reliability will be estimated from a subgroup of the study subjects (10 subjects) who receive additional scan within 4 weeks since baseline image. In order to refine the definition of a positive 18F-DTBZ in patient with PD as compared to healthy control, quantitative measurement will be used. The standard uptake value (SUV) of each brain regions will be calculated. The SUV is a widely used, simple PET quantifier, calculated as a ratio of tissue radioactivity concentration (e.g. in units kBq/ml) at time t, CPET(t) and injected dose (e.g. in units MBq) at the time of injection divided by body weight (e.g. in units kg).SUV = CPET(t) / (Injected dose / Patient's weight), t =90min, and the unit of SUV is g/ml. | A subgroup of 10 subjects receive additional scan for a test/retest reliability study | Posted | Mean | 80% Confidence Interval | g/mL | three years |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |