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Evaluation of Reader Training Processes

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: NCT02051790
Recruitment Status : Completed
First Posted : January 31, 2014
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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Brief Summary:
This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Reader Training Processes by Comparing Clinical Interpretations to Centralized Expert Reads
Study Start Date : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 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: Clinical Practice Scans
Approximately 250 florbetapir F 18 scans and final scan reports interpreted in a clinical setting will be collected from physicians across the country. These results will then be compared to expert panel interpretations for the same scans.
 Drug: florbetapir F 18
No study drug will be administered in this study - scans previously acquired in the course of clinical practice.
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir


Outcome Measures
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Primary Outcome Measures :
  1. Agreement Between Expert Panel and Clinical Practice Reads [ Time Frame: Scan acquired 50-60 minutes post injection ]
    Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Scan obtained for clinical reasons

Exclusion Criteria:

- None

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): NCT02051790


Locations
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United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Director: Chief Medical Officer Avid Radiopharmaceuticals
More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02051790    
Other Study ID Numbers: 18F-AV-45-RTP01
First Posted: January 31, 2014    Key Record Dates
Results First Posted: September 28, 2015
Last Update Posted: September 28, 2015
Last Verified: August 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