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Completed

NCT Number: NCT01946243

The Feasibility of Florbetapir Quantitation

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.

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Key information

Conditions

Alzheimers Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Philadelphia, Pennsylvania, 19103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Florbetapir F18

Drug

No Florbetapir F 18 will be administered in this study.

Other names: Amyvid, 18F-AV-45, florbetapir

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

The Feasibility and Reliability of Utilizing Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Qualitative Interpretation of Amyvid Brain Scans

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2013
Registry last updated
Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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