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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01672827
First received: August 22, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. [ Time Frame: Post flutemetamol administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post Flutemetamol Injection ] [ Designated as safety issue: No ]
    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.


Enrollment: 276
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • [18F]Flutemetamol
  • Flutemetamol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • Not Applicable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672827

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

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01672827     History of Changes
Other Study ID Numbers: GE-067-021
Study First Received: August 22, 2012
Results First Received: August 14, 2013
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014