Evaluation of Physician Training Methods to Read Florbetapir-PET Scans

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: florbetapir F 18


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: florbetapir F 18|IV injection, 370MBq (10mCi), single dose|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque | 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. | 50-60 min after injection | 
| Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque | 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. | 50-60 min after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-reader Agreement | Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers | 50-60 min after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging