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Evaluation of Physician Training Methods to Read Florbetapir-PET Scans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01565369
First received: March 26, 2012
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had an autopsy to reveal the subject's true amyloid status.


Condition Intervention
Alzheimer's Disease
 Drug: florbetapir F 18

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Validation of Binary Image Rating Methodology Using Amyloid Histopathology at Autopsy as the Reference Standard.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
    Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.

  • Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
    Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.


Secondary Outcome Measures:
  • Inter-reader Agreement [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
    Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers


Enrollment: 35
Study Start Date: January 2011
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: florbetapir F 18
    IV injection, 370MBq (10mCi), single dose
    Other Names:
    • 18F-AV-45
    • Amyvid
    • florbetapir
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Study A07[NCT00857415]):

  • Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
  • Can tolerate a 10 minute PET scan; and
  • Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.

Exclusion Criteria (Study A07[NCT00857415]):

  • Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
  • Have any major, focal structural loss of brain matter;
  • Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
  • Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
  • Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
  • Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
  • Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
  • Are females of childbearing potential who are pregnant or not using adequate contraception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565369

Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01565369     History of Changes
Other Study ID Numbers: 18F-AV-45-A08
Study First Received: March 26, 2012
Results First Received: April 6, 2012
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:
Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging

Additional relevant MeSH terms:
Alzheimer Disease
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 May 23, 2013