Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
|ClinicalTrials.gov Identifier: NCT01092546|
Recruitment Status : Terminated (Changed focus of the program)
First Posted : March 25, 2010
Results First Posted : November 19, 2013
Last Update Posted : December 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Normal Pressure Hydrocephalus||Drug: [18F]Flutemetamol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Principal, Prospective, Open-label Biopsy Study to Validate Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Normal Pressure Hydrocephalus (NPH) Subjects.|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
|Experimental: Arm 1||
All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
- 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 ]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 obtained during shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.
- Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region. [ Time Frame: Post flutemetamol administration ]The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092546
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Kim A Mansfield, MS||GE Healthcare|