Trial record 6 of 63 for:    avid

Evaluation of Reader Training Processes

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Avid Radiopharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02051790
First received: January 30, 2014
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.


Condition Intervention Phase
Alzheimer's Disease
Drug: florbetapir F 18
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Reader Training Processes by Comparing Clinical Interpretations to Centralized Expert Reads

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Agreement between expert panel and clinical practice reads [ Time Frame: Scan acquired 50-60 minutes post injection ] [ Designated as safety issue: No ]
    Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations will be calculated as a weighted Kappa value across all cases and all clinical practice readers.


Estimated Enrollment: 250
Study Start Date: March 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clinical Practice Scans
Approximately 250 florbetapir F 18 scans and final scan reports interpreted in a clinical setting will be collected from physicians across the country. These results will then be compared to expert panel interpretations for the same scans.
Drug: florbetapir F 18
No study drug will be administered in this study - scans previously acquired in the course of clinical practice.
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Scan obtained for clinical reasons

Exclusion Criteria:

- None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051790

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

Locations
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02051790     History of Changes
Other Study ID Numbers: 18F-AV-45-RTP01
Study First Received: January 30, 2014
Last Updated: March 5, 2014
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 July 20, 2014