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

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ClinicalTrials.gov Identifier: NCT01550549
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : June 7, 2012
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 6, 2012
First Posted Date  ICMJE March 12, 2012
Results First Submitted Date  ICMJE April 6, 2012
Results First Posted Date  ICMJE June 7, 2012
Last Update Posted Date June 7, 2012
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2012)
Inter-rater Reliability [ Time Frame: Scan acquired 50-60 min post-injection ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
Inter-rater Reliability [ Time Frame: Scan acquired 30-50 min post-injection ]
Fleiss' kappa
Change History Complete list of historical versions of study NCT01550549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2012)
  • 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 ]
    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 ]
    Calculated as the percent of true negatives which are correctly identified
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
Sensitivity and specificity of florbetapir-PET [ Time Frame: Scan acquired 30-50 min post-injection ]
1) sensitivity will be calculated as the percent of true positives which are correctly identified; 2) specificity will be calculated as the percent of true negatives which are correctly identified
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans
Official Title  ICMJE Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans
Brief Summary This study will investigate the performance of physician readers trained to read florbetapir-PET scans using electronic media training.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Alzheimer Disease
  • Mild Cognitive Impairment
  • Neurodegenerative Diseases
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2012)
151
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01550549
Other Study ID Numbers  ICMJE 18F-AV-45-PT01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avid Radiopharmaceuticals
Study Sponsor  ICMJE Avid Radiopharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
PRS Account Avid Radiopharmaceuticals
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP