Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images

To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq.
The subject was classified as one of the following:

End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status.
Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status.
Elderly healthy volunteer (age ≥55).
Young healthy volunteer (age ≤40).
Subject with probable Alzheimer Disease (pAD).
Subject with amnestic Mild Cognitive Impairment (aMCI).

Exclusion criteria

Not Applicable

Treatment and study plan

[18F]Flutemetamol

Drug

No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.

Other names: Flutemetamol

Primary outcomes

Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.

Time frame: Post flutemetamol administration

Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.

Time frame: Post flutemetamol administration

Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.

Secondary outcomes

Inter-Reader Agreement of PET Images Without Anatomic Images

Time frame: Post Flutemetamol Injection

Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

A Study to Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images.

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Aug 27, 2012
Registry last updated: Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed