Clinical Trial: PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: This study will determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).

Detailed Summary:
Sponsor: GE Healthcare

Current Primary Outcome:

  • 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.


Original Primary Outcome: Determine level association between quantitative estimates of brain uptake [18F]flutemetamol and quantitative immunohistochemical estimates of amyloid levels in biopsy obtained during shunt placement in patients who have normal pressure hydrocephalus. [ Time Frame: Time zero equals the date of PET imaging. A follow-up phone call approximately 24 hours after the [18F]flutemetamol will be made to assess potential adverse events. ]

Current Secondary Outcome: 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.


Original Secondary Outcome: Determine level of association between SUVR and quantitative estimates (area percents) of amyloid levels for the following regions:Ipsilateral and Contralateral. [ Time Frame: Time zero equals the date of PET imaging. A follow-up phone call approximately 24 hours after the [18F]flutemetamol will be made to assess potential adverse events. ]

Information By: GE Healthcare

Dates:
Date Received: January 19, 2010
Date Started: December 2009
Date Completion:
Last Updated: June 7, 2012
Last Verified: June 2012