Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01550549|
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : June 7, 2012
Last Update Posted : June 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Mild Cognitive Impairment Neurodegenerative Diseases||Drug: florbetapir F 18||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
U.S. FDA Resources
Drug: florbetapir F 18
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550549
|Study Director:||Chief Medical Officer||Avid Radiopharmaceuticals|