Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01550549
First received: March 6, 2012
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

This study will investigate the performance of physician readers trained to read florbetapir-PET scans using electronic media training.


Condition Intervention
Alzheimer Disease
Mild Cognitive Impairment
Neurodegenerative Diseases
Drug: florbetapir F 18

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Inter-rater Reliability [ Time Frame: Scan acquired 50-60 min post-injection ] [ Designated as safety issue: No ]
    Measure of agreement among five readers using a binary read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.


Secondary Outcome Measures:
  • Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease) [ Time Frame: at autopsy, within 2 years of scan ] [ Designated as safety issue: No ]
    Calculated as the percent of true positives which are correctly identified

  • Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease) [ Time Frame: at autopsy, within 2 years of scan ] [ Designated as safety issue: No ]
    Calculated as the percent of true negatives which are correctly identified


Enrollment: 151
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: florbetapir F 18
    No study drug will be administered in this study - scans previously acquired in in Study A05(NCT00702143) and A07(NCT00857415) will be read
    Other Names:
    • 18F-AV-45
    • Amyvid
    • florbetapir
Detailed Description:

Avid has previously developed a florbetapir-PET scan binary read methodology and training program, which was successfully applied in studies 18F-AV-45-A08(NCT01565369), 18F-AV-45-A09(NCT01565382) and 18F-AV-45-A16(NCT01447719). In these previous studies, training was conducted in-person. Study 18F-AV-45-PT01 will evaluate an automated version of this training program suitable for web-based distribution. Nuclear medicine physicians will complete the automated training program then read the florbetapir-PET images from 151 subjects with repeat readings of 33 randomly selected images. Readers will rate each case as either positive for significant tracer accumulation in cortical gray matter or negative for significant tracer accumulation in cortical gray matter. The inter-rater reliability, sensitivity and specificity of the readers will be evaluated.

The primary image set for determination of inter-reader agreement is comprised of images from 119 subjects from two previous clinical studies (A07[NCT00857415]/A16[NCT01447719] and A05[NCT00702143]). This included all 59 subjects who came to autopsy in Study A07(NCT00857415) and it's follow-up study, A16(NCT01447719), and a set of 60 cases randomly selected from Study A05(NCT00702143) subjects, including 20 cognitively-normal controls, 20 with mild cognitive impairment) MCI, 20 with AD.

Subsequently, the protocol was amended to include all remaining A05(NCT00702143) MCI patients that were not used in the training program (n=32); 13 of these 32 scans presented for repeat reading (to increase the number of A05 MCI cases with repeated reads to 20). This increased the number of unique cases in the validation dataset to 151 scans with 33 scans repeated yielding a total of 184 scans reviewed by the readers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A05 (NCT00702143) or A07 (NCT00857415).

Alzheimer's disease (AD) group key eligibility criteria (from Study A05[NCT00702143]):

  • Male or female at least 50 years of age
  • Have probable AD per National Institute of Neurological and Communication Disorders and Stroke (NINCDS) criteria
  • Mini mental state exam (MMSE) score between 10 and 24 inclusive

Mild cognitive impairment group key eligibility criteria (from Study A05[NCT00702143):

  • Male or female at least 50 years of age
  • Complaints of memory or cognitive decline corroborated by an informant
  • Clinical dementia rating of 0.5
  • No obvious cause for cognitive impairment (eg, head trauma or stroke)
  • Cognitive impairment onset within the past year
  • MMSE score greater than 24

Cognitively normal volunteer group key eligibility criteria (from Study A05[NCT00702143]):

  • Male or female at least 50 years of age
  • MMSE score greater than or equal to 29 and cognitively normal by informant report and psychometric test battery at screening

Autopsy cohort key eligibility criteria (from Study A07[NCT00857415]):

  • Male or female 18 years or older
  • Projected life expectancy of less than 6 months
  • Consent to brain donation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550549

Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01550549     History of Changes
Other Study ID Numbers: 18F-AV-45-PT01
Study First Received: March 6, 2012
Results First Received: April 6, 2012
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:
Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 21, 2014