Evaluation of Physician Training Methods to Read Florbetapir-PET Scans

Alzheimer's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565369
• Other study ID #: 18F-AV-45-A08
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: May 3, 2012
• Start date: January 2011
• Est. completion date: January 2011

Study information

• Verified date: May 2012
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• florbetapir F 18
IV injection, 370MBq (10mCi), single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Inter-reader Agreement	Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers	50-60 min after injection	No