The Feasibility of Florbetapir Quantitation in Europe

NCT02107599 | Completed Phase 4 Results

• 1 other identifier: 18F-AV-45-QP02
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Change in Reader Accuracy After Application of Quantitation Software

  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.

  Scan acquired 50-60 minutes post injection

Secondary Outcomes (1)

• Change in Scan Interpretation Reliability After Application of Quantitation Software

  Scan acquired 50-60 minutes 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(18F) as part of this study.

Drug: Florbetapir (18F)

Interventions

Florbetapir (18F) DRUG

No Florbetapir (18F) will be administered in this study.

Also known as: Florbetapir F 18, Amyvid, 18F-AV-45

Physician Readers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Readers have undergone Amyvid reader training
• Readers have not more than minimal experience with quantitation of amyloid PET scans

You may not qualify if:

• Readers have previously been trained to quantitate amyloid PET scans

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (1)

Research Site

Leiden, 2316XC, Netherlands

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

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: April 4, 2014
• First Posted: April 8, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 9, 2015
• Results First Posted: July 9, 2015

Record last verified: 2015-06

Locations

NL (1)