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

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ClinicalTrials.gov Identifier: NCT01672827
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : December 19, 2013
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Drug: [18F]Flutemetamol Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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 Start Date : July 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: [18F]Flutemetamol Drug: [18F]Flutemetamol
No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.
Other Name: Flutemetamol



Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672827


Sponsors and Collaborators
GE Healthcare
Investigators
Study Chair: Paul Sherwin, MD GE Healthcare

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01672827     History of Changes
Other Study ID Numbers: GE-067-021
First Posted: August 27, 2012    Key Record Dates
Results First Posted: December 19, 2013
Last Update Posted: January 24, 2014
Last Verified: December 2013

Keywords provided by GE Healthcare:
Alzheimer's Disease
Mild Cognitive Impairment
Positron Emission Tomography (PET)
PET Images

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders