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Evaluation of Physician Training Methods to Read Florbetapir-PET Scans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565369
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : June 7, 2012
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: florbetapir F 18 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (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.
Study Start Date : January 2011
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011



Intervention Details:
  • Drug: florbetapir F 18
    IV injection, 370MBq (10mCi), single dose
    Other Names:
    • 18F-AV-45
    • Amyvid
    • florbetapir


Primary Outcome Measures :
  1. Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque [ Time Frame: 50-60 min after injection ]
    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.

  2. Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque [ Time Frame: 50-60 min after injection ]
    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 :
  1. Inter-reader Agreement [ Time Frame: 50-60 min after injection ]
    Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT01565369


Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Director: Chief Medical Officer Avid Radiopharmaceuticals
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01565369    
Other Study ID Numbers: 18F-AV-45-A08
First Posted: March 28, 2012    Key Record Dates
Results First Posted: June 7, 2012
Last Update Posted: June 7, 2012
Last Verified: May 2012
Keywords provided by Avid Radiopharmaceuticals:
Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders