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The Feasibility of Florbetapir Quantitation in Europe

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: NCT02107599
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : July 9, 2015
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Brief Summary:
This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Florbetapir (18F) Phase 4

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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: A Study to Evaluate the Improvement in Reader Accuracy When Using a Read Method That Incorporates Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Visual Interpretation of Amyvid Brain Scans
Study Start Date : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

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(18F) as part of this study.
Drug: Florbetapir (18F)
No Florbetapir (18F) will be administered in this study.
Other Names:
  • Florbetapir F 18
  • Amyvid
  • 18F-AV-45




Primary Outcome Measures :
  1. Change in Reader Accuracy After Application of Quantitation Software [ Time Frame: Scan acquired 50-60 minutes post injection ]

    Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.

    NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative

    Only the 46 scans with autopsy from A16 are used for this outcome measure.



Secondary Outcome Measures :
  1. Change in Scan Interpretation Reliability After Application of Quantitation Software [ Time Frame: Scan acquired 50-60 minutes post injection ]

    Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.

    NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative

    Only the 46 scans with autopsy from A16 are used for this outcome measure.




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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 not more than minimal experience with quantitation of amyloid PET scans

Exclusion Criteria:

  • Readers have previously been trained to quantitate amyloid PET scans

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): NCT02107599


Locations
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Netherlands
Research Site
Leiden, Netherlands, 2316XC
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Director: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02107599    
Other Study ID Numbers: 18F-AV-45-QP02
First Posted: April 8, 2014    Key Record Dates
Results First Posted: July 9, 2015
Last Update Posted: July 9, 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