Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01672827
First received: August 22, 2012
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • The blinded visual assessment (conducted by 5 blinded independent readers) of each subject's [18F]flutemetamol PET scan images, as normal or abnormal, without anatomic images. [ Time Frame: Scans were previously acquired 90 minutes post tracer injection. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The blinded visual assessment (conducted by 5 blinded independent readers) of each subject's [18F]flutemetamol PET scan images, as normal or abnormal, with all available anatomic images. [ Time Frame: Scans were previously acquired 90 minutes post tracer injection. ] [ Designated as safety issue: No ]

Enrollment: 276
Study Start Date: July 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 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
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
Last Updated: August 27, 2012
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
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 June 18, 2013