- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051790
Evaluation of Reader Training Processes
August 27, 2015 updated by: Avid Radiopharmaceuticals
Evaluation of Reader Training Processes by Comparing Clinical Interpretations to Centralized Expert Reads
This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
241
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Scan obtained for clinical reasons
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
No study drug will be administered in this study - scans previously acquired in the course of clinical practice.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement Between Expert Panel and Clinical Practice Reads
Time Frame: Scan acquired 50-60 minutes post injection
|
Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.
|
Scan acquired 50-60 minutes post injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
January 30, 2014
First Submitted That Met QC Criteria
January 30, 2014
First Posted (Estimate)
January 31, 2014
Study Record Updates
Last Update Posted (Estimate)
September 28, 2015
Last Update Submitted That Met QC Criteria
August 27, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18F-AV-45-RTP01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer's Disease
-
University of Southern CaliforniaAlzheimer's Therapeutic Research Institute; American Heart Association; Schaeffer...RecruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Brigham and Women's Hospital and other collaboratorsActive, not recruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease | Normal CognitionUnited States
-
University Hospital, BordeauxMinistry for Health and Solidarity, FranceCompletedAlzheimer's Disease (AD) | Alzheimer's Disease (AD) Related DisordersFrance
-
University of Colorado, DenverNational Institute on Aging (NIA)Active, not recruitingSuspected Typical Alzheimer's Disease (AD) | Suspected Atypical Alzheimer's Disease (AD)United States
Clinical Trials on florbetapir F 18
-
Brigham and Women's HospitalTerminatedCardiac AmyloidosisUnited States
-
Avid RadiopharmaceuticalsWithdrawnAlzheimer's DiseaseJapan
-
Avid RadiopharmaceuticalsCompletedProgressive Cognitive DeclineUnited States
-
Avid RadiopharmaceuticalsNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedParkinson's DiseaseUnited States
-
Avid RadiopharmaceuticalsCompletedAlzheimer DiseaseUnited States
-
Avid RadiopharmaceuticalsCompletedAlzheimer's Disease
-
Avid RadiopharmaceuticalsCompletedMild Cognitive Impairment | Alzheimer's DiseaseUnited States
-
Chang Gung Memorial HospitalUnknown
-
Avid RadiopharmaceuticalsCompletedNeurodegenerative Diseases | Alzheimer Disease | Mild Cognitive Impairment
-
Avid RadiopharmaceuticalsCompletedAlzheimer's Disease