NCT01946243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 1, 2015

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

September 17, 2013

Results QC Date

April 27, 2015

Last Update Submit

June 1, 2015

Conditions

Alzheimers Disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    Scan acquired 50-60 min post-injection

  • 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.

    Scan acquired 50-60 min post-injection

Secondary Outcomes (4)

  • Change in Total Accuracy (MIMNeuro Software, All Readers)

    Scan acquired 50-60 min post-injection

  • Change in Reliability (MIMNeuro Software)

    Scan acquired 50-60 min post-injection

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

    Scan acquired 50-60 min post-injection

  • Change in Reliability (Siemens Syngo.PET Software)

    Scan acquired 50-60 min post-injection

Study Arms (1)

Physician Readers

EXPERIMENTAL

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

Interventions

Florbetapir F18DRUG

No Florbetapir F 18 will be administered in this study.

Also known as: Amyvid, 18F-AV-45, florbetapir
Physician Readers

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Readers have undergone Amyvid reader training
  • Readers have minimal experience with quantitation of amyloid PET scans

You may not qualify if:

  • Readers have previously been trained to quantitate amyloid PET scans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Limitations and Caveats

No conclusions can be drawn regarding the relative performance of software packages (different readers) or on impact of additional qualitative practice on quantitative interpretation results (Vis Q always after Qualitative).

Results Point of Contact

Title
Chief Medical Officer
Organization
Avid Radiopharmaceuticals
clinicaloperations@avidrp.com
215-298-0700

Study Officials

  • Chief Medical Officer

    Avid Radiopharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 19, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 29, 2015

Results First Posted

June 1, 2015

Record last verified: 2015-06

Locations

US(1)