PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
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|ClinicalTrials.gov Identifier: NCT01053312|
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : June 5, 2012
Last Update Posted : June 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Normal Pressure Hydrocephalus||Drug: [18F] Flutemetamol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||August 2010|
|Experimental: 1 flutemetamol||
Drug: [18F] Flutemetamol
All subjects will receive an intravenous (IV) dose of [18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels (MBq).
- Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. [ Time Frame: Post-contrast administration ]Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV_voi/SUV_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV_voi) or reference region (SUV_ref). VOI means volume of interest and REF means reference region.
- Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. [ Time Frame: Post-contrast administration ]This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.
- Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects [ Time Frame: Post-contrast Administration ]Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053312
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Kim A Mansfield, MS||GE Healthcare|