Evaluation of Physician Training Methods to Read Florbetapir-PET Scans

NCT01565369 | Completed Results

• 1 other identifier: 18F-AV-45-A08
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer's Disease

Keywords

Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Inter-reader Agreement

  50-60 min after injection

Interventions

florbetapir F 18 DRUG

IV injection, 370MBq (10mCi), single dose

Also known as: 18F-AV-45, Amyvid, florbetapir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avid Radiopharmaceuticals

clinicaloperations@avidrp.com

215-798-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 7, 2012
• Results First Posted: June 7, 2012

Record last verified: 2012-05