Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem

Completed

• Conditions: Cognitive Impairment

• Registration Number: NCT02090855
• Lead Sponsor: GE Healthcare

Brief Summary

Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain images previously obtained in Study GE-067-007 will be interpreted visually in randomized by 5 independent readers who are blinded to all other subject information, and the images will be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative for abnormal neuritic plaque density). The numbers of images in each category will be used to calculate sensitivity and specificity.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Results First Submitted: 2014-07-18
• Results First Submitted QC: 2014-08-12
• Results First Posted: 2014-08-27
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• The subject was enrolled in prior Study GE067-007.
• The subject died on or before 10 June 2013.
• The subject's brain is judged to be of suitable quality for analysis, including all regions necessary for analysis.

Exclusion Criteria

• Not Applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Number of Abnormal Blinded Visual PET Image Interpretations.	Brain images will be assessed up to 1 year post subject's death.	Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.
Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans	Brain images will be assessed up to 1 year post subject's death.	Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.

Secondary Outcome Measures

Name	Time	Method
Number of Blinded Visual PET Image Interpretations	Brain images will be assessed up to 1 year post subject's death.	Specificity of blinded visual image interpretations according to neuropathological criteria.
Specificity Percentage of Blinded Visual PET Image Interpretations	Brain images will be assessed up to 1 year post subject's death.	Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States