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The Feasibility of Florbetapir Quantitation

Sponsor
Avid Radiopharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01946243
Collaborator
(none)
96
Enrollment
1
Location
1
Arm
8
Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.

Condition or Disease Intervention/Treatment Phase
  • Drug: Florbetapir F18
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
The Feasibility and Reliability of Utilizing Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Qualitative Interpretation of Amyvid Brain Scans
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physician Readers

Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir F 18 as part of this study.

Drug: Florbetapir F18
No Florbetapir F 18 will be administered in this study.
Other Names:
  • Amyvid
  • 18F-AV-45
  • florbetapir

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers) [Scan acquired 50-60 min post-injection]

      Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.

    2. Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers) [Scan acquired 50-60 min post-injection]

      Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.

    Secondary Outcome Measures

    1. Change in Total Accuracy (MIMNeuro Software, All Readers) [Scan acquired 50-60 min post-injection]

      Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.

    2. Change in Reliability (MIMNeuro Software) [Scan acquired 50-60 min post-injection]

      Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.

    3. Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers) [Scan acquired 50-60 min post-injection]

      Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.

    4. Change in Reliability (Siemens Syngo.PET Software) [Scan acquired 50-60 min post-injection]

      Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Readers have undergone Amyvid reader training

    • Readers have minimal experience with quantitation of amyloid PET scans

    Exclusion Criteria:
    • Readers have previously been trained to quantitate amyloid PET scans

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Philadelphia Pennsylvania United States 19103

    Sponsors and Collaborators

    • Avid Radiopharmaceuticals

    Investigators

    • Study Director: Chief Medical Officer, Avid Radiopharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Avid Radiopharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01946243
    Other Study ID Numbers:
    • 18F-AV-45-QP01
    First Posted:
    Sep 19, 2013
    Last Update Posted:
    Jun 29, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Florbetapir PET Scans
    Arm/Group Description No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
    Period Title: Overall Study
    STARTED 96
    COMPLETED 96
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Florbetapir PET Scans
    Arm/Group Description No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
    Overall Participants 96
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    76.9
    (10.23)
    Sex: Female, Male (Count of Participants)
    Female
    48
    50%
    Male
    48
    50%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    4.2%
    Not Hispanic or Latino
    92
    95.8%
    Unknown or Not Reported
    0
    0%
    Race/Ethnicity, Customized (participants) [Number]
    Asian
    1
    1%
    Black or African American
    5
    5.2%
    White
    89
    92.7%
    Other
    1
    1%
    Region of Enrollment (participants) [Number]
    United States
    96
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)
    Description Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
    Time Frame Scan acquired 50-60 min post-injection

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Qualitative VisQ Change
    Arm/Group Description Qualitative scan interpretation only Quantitation as an adjunct to qualitative scan interpretation Change = VisQ - Qualitative
    Measure Participants 46 46 46
    Mean (Standard Error) [Percent Accuracy]
    81.7
    (2.4)
    88.8
    (3.1)
    7.1
    (1.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Change
    Comments Paired t-test to test whether the change is equal to zero or not.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments
    Method t-test, 2 sided
    Comments
    2. Secondary Outcome
    Title Change in Total Accuracy (MIMNeuro Software, All Readers)
    Description Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
    Time Frame Scan acquired 50-60 min post-injection

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Qualitative VisQ Change
    Arm/Group Description Qualitative scan interpretation only Quantitation as an adjunct to qualitative scan interpretation Change = VisQ - Qualitative
    Measure Participants 46 46 46
    Mean (Standard Error) [Percent Accuracy]
    89.5
    (1.4)
    93.8
    (1.2)
    4.2
    (0.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Change
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 4.2
    Confidence Interval (1-Sided) 97.5%
    2.7 to
    Parameter Dispersion Type:
    Value:
    Estimation Comments Units: Percent Accuracy
    3. Secondary Outcome
    Title Change in Reliability (MIMNeuro Software)
    Description Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.
    Time Frame Scan acquired 50-60 min post-injection

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Qualitative VisQ Change
    Arm/Group Description Qualitative scan interpretation only Quantitation as an adjunct to qualitative scan interpretation Change = VisQ - Qualitative
    Measure Participants 96 96 96
    All study cases
    0.72
    0.79
    0.06
    Autopsy cases
    0.73
    0.81
    0.08
    Non-autopsy cases
    0.72
    0.77
    0.05
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Change
    Comments Superiority demonstrated if lower bound of two-sided 95% confidence interval (CI) greater than 0, for the change in kappa statistic.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter lower bound of two-sided 95% CI
    Estimated Value 0.06
    Confidence Interval (2-Sided) 95%
    0.018 to 0.112
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)
    Description Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
    Time Frame Scan acquired 50-60 min post-injection

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Qualitative VisQ Change
    Arm/Group Description Qualitative scan interpretation only Quantitation as an adjunct to qualitative scan interpretation Change = VisQ - Qualitative
    Measure Participants 46 46 46
    Mean (Standard Error) [Percent Accuracy]
    91.6
    (0.8)
    93.9
    (0.7)
    2.3
    (0.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Change
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 2.3
    Confidence Interval (1-Sided) 97.5%
    0.8 to
    Parameter Dispersion Type:
    Value:
    Estimation Comments Units: Percent Accuracy
    5. Secondary Outcome
    Title Change in Reliability (Siemens Syngo.PET Software)
    Description Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.
    Time Frame Scan acquired 50-60 min post-injection

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Qualitative VisQ Change
    Arm/Group Description Qualitative scan interpretation only Quantitation as an adjunct to qualitative scan interpretation Change = VisQ - Qualitative
    Measure Participants 96 96 96
    All study cases
    0.75
    0.82
    0.07
    Autopsy cases
    0.76
    0.80
    0.04
    Non-autopsy cases
    0.73
    0.83
    0.10
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Change
    Comments Superiority demonstrated if lower bound of two-sided 95% CI greater than 0, for the change in kappa statistic.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0280
    Comments
    Method Monte Carlo test
    Comments
    Method of Estimation Estimation Parameter lower bound of two-sided 95% CI
    Estimated Value 0.07
    Confidence Interval (2-Sided) 95%
    0.007 to 0.125
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Primary Outcome
    Title Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)
    Description Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.
    Time Frame Scan acquired 50-60 min post-injection

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Qualitative VisQ Change
    Arm/Group Description Qualitative scan interpretation only Quantitation as an adjunct to qualitative scan interpretation Change = VisQ - Qualitative
    Measure Participants 46 46 46
    Mean (Standard Error) [Percent Accuracy]
    87.0
    (1.0)
    91.8
    (1.1)
    4.9
    (1.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Change
    Comments Paired t-test to test whether the change is equal to zero or not.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0025
    Comments
    Method t-test, 2 sided
    Comments

    Adverse Events

    Time Frame
    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 (A07, A16, and A17).
    Arm/Group Title Florbetapir PET Scans
    Arm/Group Description No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A07/A16 and A17).
    All Cause Mortality
    Florbetapir PET Scans
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Florbetapir PET Scans
    Affected / at Risk (%) # Events
    Total 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Florbetapir PET Scans
    Affected / at Risk (%) # Events
    Total 0/0 (NaN)

    Limitations/Caveats

    No conclusions can be drawn regarding the relative performance of software packages (different readers) or on impact of additional qualitative practice on quantitative interpretation results (Vis Q always after Qualitative).

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT 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

    Name/Title Chief Medical Officer
    Organization Avid Radiopharmaceuticals
    Phone 215-298-0700
    Email clinicaloperations@avidrp.com
    Responsible Party:
    Avid Radiopharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01946243
    Other Study ID Numbers:
    • 18F-AV-45-QP01
    First Posted:
    Sep 19, 2013
    Last Update Posted:
    Jun 29, 2015
    Last Verified:
    Jun 1, 2015