Back to resultsEffectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images
Primary Purpose
Alzheimer's Disease, Mild Cognitive Impairment
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
[18F]Flutemetamol
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Mild Cognitive Impairment, Positron Emission Tomography (PET), PET Images
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]Flutemetamol
Arm Description
Outcomes
Primary Outcome Measures
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.
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.
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 Outcome Measures
Inter-Reader Agreement of PET Images Without Anatomic Images
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01672827
Brief Title
Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images
Official Title
A Study to Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment
Keywords
Alzheimer's Disease, Mild Cognitive Impairment, Positron Emission Tomography (PET), PET Images
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[18F]Flutemetamol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[18F]Flutemetamol
Other Intervention Name(s)
Flutemetamol
Intervention Description
No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.
Primary Outcome Measure Information:
Title
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.
Description
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.
Time Frame
Post flutemetamol administration
Title
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.
Description
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.
Time Frame
Post flutemetamol administration
Secondary Outcome Measure Information:
Title
Inter-Reader Agreement of PET Images Without Anatomic Images
Description
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.
Time Frame
Post Flutemetamol Injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sherwin, MD
Organizational Affiliation
GE Healthcare
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images
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