Clinical Trial: Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Principal, Prospective, Open-label Biopsy Study to Validate Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Normal Pressure Hydrocephalus (NP
Brief Summary: To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.
Detailed Summary:
Sponsor: GE Healthcare
Current Primary Outcome: Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region. [ Time Frame: Post flutemetamol Injection ]
Original Primary Outcome: Brain uptake of [18F]flutemetamol [ 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 (AEs). ]
Current Secondary Outcome: Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region. [ Time Frame: Post flutemetamol administration ]
Original Secondary Outcome: Level of association between SUVR and the quantitative estimates of amyloid levels [ 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 (AEs). ]
Information By: GE Healthcare
Dates:
Date Received: March 23, 2010
Date Started: March 2010
Date Completion:
Last Updated: November 20, 2013
Last Verified: November 2013
