Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
|ClinicalTrials.gov Identifier: NCT01265394|
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : June 21, 2013
Last Update Posted : July 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: [18F] Flutemetamol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40|
|Study Start Date :||December 2010|
|Primary Completion Date :||March 2011|
|Study Completion Date :||April 2011|
|Experimental: (18F) Flutemetamol||
Drug: [18F] Flutemetamol
Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Other Name: AH110690
- Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid [ Time Frame: PET scans performed on patients 90 minutes post Flutemetmol Administration ]
The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.
The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).
- Measurement of Amyloid Content in Different Parts of the Brain [ Time Frame: PET scans performed on patients 90 minutes post Flutemetmol Administration ]
Is the computerized measurement of amyloid content in different parts of the brain.
The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.
The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.
The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265394
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Paul Sherwin, MD, PhD||GE Healthcare|