Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
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|ClinicalTrials.gov Identifier: NCT01556100|
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: 18F-DTBZ AV-133||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression|
|Study Start Date :||November 2011|
|Primary Completion Date :||May 2015|
|Study Completion Date :||December 2015|
Experimental: 18F-DTBZ AV-133
18F-DTBZ AV-133 imaging
Drug: 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.
- Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36 [ Time Frame: three years ]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.
- To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients. [ Time Frame: three years ]
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.