Trial record 8 of 61 for:    avid

The Feasibility of Florbetapir Quantitation

This study is currently recruiting participants.
Verified November 2013 by Avid Radiopharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01946243
First received: September 17, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Alzheimers Disease
Drug: Florbetapir F18
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Change in reader accuracy after application of quantitation software [ Time Frame: Scan acquired 50-60 min post injection ] [ Designated as safety issue: No ]
    Evaluate whether the use of quantitation software improves the total accuracy of florbetapir F 18 scan interpretation. Total accuracy is defined as the number of scans correctly interpreted (vs. a truth standard) divided by the total number of scans read.


Secondary Outcome Measures:
  • Change in scan interpretation reliability after application of quantitation software [ Time Frame: Scan acquired 50-60 min post injection ] [ Designated as safety issue: No ]
    Evaluate whether the use of quantitation software improves the reliability of florbetapir F 18 scan interpretation. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.


Estimated Enrollment: 96
Study Start Date: August 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physician Readers
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
No Florbetapir F 18 will be administered in this study.
Other Names:
  • Amyvid
  • 18F-AV-45
  • florbetapir

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946243

Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

Locations
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01946243     History of Changes
Other Study ID Numbers: 18F-AV-45-QP01
Study First Received: September 17, 2013
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014