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The Feasibility of Florbetapir Quantitation

Primary Purpose

Alzheimers Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Florbetapir F18
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimers Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physician Readers

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)
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.
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)
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

Change in Total Accuracy (MIMNeuro Software, All Readers)
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.
Change in Reliability (MIMNeuro Software)
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.
Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)
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.
Change in Reliability (Siemens Syngo.PET Software)
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.

Full Information

First Posted
September 17, 2013
Last Updated
June 1, 2015
Sponsor
Avid Radiopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01946243
Brief Title
The Feasibility of Florbetapir Quantitation
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimers Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physician Readers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Florbetapir F18
Other Intervention Name(s)
Amyvid, 18F-AV-45, florbetapir
Intervention Description
No Florbetapir F 18 will be administered in this study.
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
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
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
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Feasibility of Florbetapir Quantitation

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