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The Feasibility of Florbetapir Quantitation

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: NCT01946243
Recruitment Status : Completed
First Posted : September 19, 2013
Results First Posted : June 1, 2015
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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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
Alzheimers Disease Drug: Florbetapir F18 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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): NCT01946243


Locations
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United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Director: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01946243    
Other Study ID Numbers: 18F-AV-45-QP01
First Posted: September 19, 2013    Key Record Dates
Results First Posted: June 1, 2015
Last Update Posted: June 29, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders