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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions Alzheimer Disease
Mild Cognitive Impairment
Neurodegenerative Diseases
Intervention Drug: florbetapir F 18
Enrollment 151
Recruitment Details NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies
Pre-assignment Details  
Arm/Group Title Florbetapir-PET Scans
Hide Arm/Group Description All subject scans with a valid florbetapir-PET scan
Period Title: Overall Study
Started 151
Completed 151
Not Completed 0
Arm/Group Title Florbetapir-PET Scans
Hide Arm/Group Description All subjects with a valid florbetapir-PET scan (59 from study A07/A16 and 92 from study A05)
Overall Number of Baseline Participants 151
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants
74.9  (11.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
Female
75
  49.7%
Male
76
  50.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 151 participants
151
1.Primary Outcome
Title Inter-rater Reliability
Hide Description 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.
Time Frame Scan acquired 50-60 min post-injection
Hide Outcome Measure Data
Hide Analysis Population Description
59 autopsy subjects (study A07[NCT00857415]/A16[NCT01447719]) + 20 healthy controls + 20 mild cognitive impairment + 20 AD (from study A05[NCT00702143])
Arm/Group Title Florbetapir-PET Scans Primary Analysis Group
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: kappa statistic
0.81
(0.75 to 0.87)
2.Secondary Outcome
Title Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)
Hide Description Calculated as the percent of true positives which are correctly identified
Time Frame at autopsy, within 2 years of scan
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Autopsy Autopsy Within One Year of Scan
Hide Arm/Group Description:
Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
Overall Number of Participants Analyzed 59 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of positive cases IDed
Reader 1
79
(64.5 to 89.2)
86
(68.5 to 94.3)
Reader 2
92
(79.7 to 97.3)
100
(87.9 to 100)
Reader 3
69
(53.6 to 81.4)
75
(56.6 to 87.3)
Reader 4
87
(73.3 to 94.4)
93
(77.4 to 98.0)
Reader 5
82
(67.3 to 91.0)
89
(72.8 to 96.3)
3.Secondary Outcome
Title Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)
Hide Description Calculated as the percent of true negatives which are correctly identified
Time Frame at autopsy, within 2 years of scan
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Autopsy Autopsy Within One Year of Scan
Hide Arm/Group Description:
Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
Overall Number of Participants Analyzed 59 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of negative cases IDed
Reader 1
90
(69.9 to 97.2)
89
(67.2 to 96.9)
Reader 2
90
(69.9 to 97.2)
89
(67.2 to 96.9)
Reader 3
95
(76.4 to 99.1)
94
(74.2 to 99.0)
Reader 4
95
(76.4 to 99.1)
94
(74.2 to 99.0)
Reader 5
95
(76.4 to 99.1)
100
(82.4 to 100)
4.Other Pre-specified Outcome
Title Median Sensitivity and Specificity vs. CERAD Diagnosis
Hide Description Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).
Time Frame Baseline scan
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Autopsy Population
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: percentage of true positives/negatives
Sensitivity
82
(69 to 92)
Specificity
95
(90 to 95)
5.Post-Hoc Outcome
Title Inter-reader Reliability
Hide Description Measure of agreement among multiple readers using binary read method (Fleiss' kappa). Where available, histopathology analysis at autopsy was the truth standard (TS).
Time Frame Scan acquired 50-60 min post-injection
Hide Outcome Measure Data
Hide Analysis Population Description
59 from study A07(NCT00857415)/A16(NCT01447719) and 92 from study A05(NCT00702143)
Arm/Group Title All Florbetapir-PET Scans
Hide Arm/Group Description:
All subjects with a valid florbetapir-PET scan
Overall Number of Participants Analyzed 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: kappa statistic
All subjects [n=151]
0.83
(0.78 to 0.88)
All subjects with a TS [n=59]
0.75
(0.67 to 0.83)
All subjects without a TS [n=92]
0.88
(0.82 to 0.94)
AD [n=49] (29 with TS; 20 no TS)
0.67
(0.58 to 0.76)
MCI [n=57] (5 with TS; 52 no TS)
0.91
(0.83 to 0.99)
Cognitively normal without TS [n=20]
0.83
(0.69 to 0.97)
Cognitively normal with TS [n=12]
0.73
(0.55 to 0.87)
Other (non-AD) dementia with TS [n=13]
0.52
(0.35 to 0.69)
6.Post-Hoc Outcome
Title Individual Reader Results (All Scans With Autopsy)
Hide Description Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.
Time Frame Baseline scan
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Autopsy Population
Hide Arm/Group Description:
Group of subjects with valid images who came to autopsy within 2 year of scan
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: florbetapir scans
Reader 1 - False Negatives 8
Reader 1 - False Positives 2
Reader 2 - False Negatives 3
Reader 2 - False Positives 2
Reader 3 - False Negatives 12
Reader 3 - False Positives 1
Reader 4 - False Negatives 5
Reader 4 - False Positives 1
Reader 5 - False Negatives 7
Reader 5 - False Positives 1
7.Post-Hoc Outcome
Title Individual Reader Results (Autopsy Within 1 Year of Scan)
Hide Description Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.
Time Frame Baseline scan
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autopsy Within One Year of Scan
Hide Arm/Group Description:
Group of subjects with valid images who came to autopsy within 1 year of scan
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: florbetapir scans
Reader 1 - False Negatives 4
Reader 1 - False Positives 2
Reader 2 - False Negatives 0
Reader 2 - False Positives 2
Reader 3 - False Negatives 7
Reader 3 - False Positives 1
Reader 4 - False Negatives 2
Reader 4 - False Positives 1
Reader 5 - False Negatives 3
Reader 5 - False Positives 0
Time Frame [Not Specified]
Adverse Event Reporting Description No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A05, A07, A16).
 
Arm/Group Title Florbetapir-PET Scans
Hide Arm/Group Description All subject scans with a valid florbetapir-PET scan
All-Cause Mortality
Florbetapir-PET Scans
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Florbetapir-PET Scans
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Florbetapir-PET Scans
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals
Phone: 215-298-0700
EMail: clinicaloperations@avidrp.com
Layout table for additonal information
Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01550549     History of Changes
Other Study ID Numbers: 18F-AV-45-PT01
First Submitted: March 6, 2012
First Posted: March 12, 2012
Results First Submitted: April 6, 2012
Results First Posted: June 7, 2012
Last Update Posted: June 7, 2012