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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|