- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01672827
Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images
December 18, 2013 updated by: GE Healthcare
A Study to Evaluate the 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
276
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: [18F]Flutemetamol
|
No drug is administered in this intervention.
These are scanned images being reviewed, previously acquired in various GE-067 studies.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Post flutemetamol administration
|
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.
|
Post flutemetamol administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Post Flutemetamol Injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Paul Sherwin, MD, GE Healthcare
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 22, 2012
First Submitted That Met QC Criteria
August 24, 2012
First Posted (Estimate)
August 27, 2012
Study Record Updates
Last Update Posted (Estimate)
January 24, 2014
Last Update Submitted That Met QC Criteria
December 18, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Cognition Disorders
- Alzheimer Disease
- Cognitive Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Flutemetamol
Other Study ID Numbers
- GE-067-021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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