Back to resultsEvaluation of Physician Training Methods to Read Florbetapir-PET Scans
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
florbetapir F 18
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Inter-reader Agreement
Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01565369
Brief Title
Evaluation of Physician Training Methods to Read Florbetapir-PET Scans
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
florbetapir F 18
Other Intervention Name(s)
18F-AV-45, Amyvid, florbetapir
Intervention Description
IV injection, 370MBq (10mCi), single dose
Primary Outcome Measure Information:
Title
Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque
Description
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.
Time Frame
50-60 min after injection
Title
Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque
Description
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.
Time Frame
50-60 min after injection
Secondary Outcome Measure Information:
Title
Inter-reader Agreement
Description
Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers
Time Frame
50-60 min after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Physician Training Methods to Read Florbetapir-PET Scans
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