A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe

A Post-Authorisation Safety Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training in Europe

This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment

Detailed Description

This study is a combination of Prospective and Retrospective models.

• Study Type: Observational
• Enrollment (Actual): 227

Contacts and Locations

Study Locations

• Austria
  • Vöcklabruck, Austria, 4840
    • Landeskrankenhaus Vocklabruck
  • Wagner-Jauregg-Weg
    • Linz, Wagner-Jauregg-Weg, Austria, 4020
      • Kepler Universittsklinikum Neuromed Campus
• Finland
  • Helsinki, Finland, 00209
    • Helsinki University Central Hospital
• Italy
  • Barletta, Italy, 70051
    • Ospedal Mons Dimicolli - Barletta
  • Brescia, Italy, 25123
    • U.O. Medicina Nucleare- ASSST Spedali Civili P.O. di Brescia
  • Firenze, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi - S.O.D. Patologia Medica
• Netherlands
  • Eindhoven, Netherlands, 5623
    • Catharina Ziekenhuis
• Spain
  • Barcelona, Spain, 08907
    • Hospital Universitari de Bellvitge
  • Barcelona, Spain, 08035
    • Vall d'Hebron University Hospital
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

tertiary referral

Description

Inclusion Criteria:

• The subject is an adult (aged 18 years or older) of any race or gender and has been referred for a VIZAMYL™ PET brain scan as part of the assessment of his/her cognitive impairment.
• The VIZAMYL™ scan was ordered as part of the clinical care of the subject and is not exclusively for a clinical trial.
• If informed consent is required by the local IEC, the subject, or his/her legally authorised representative, is willing and able to sign consent for use of their de-identified VIZAMYL™ PET images and associated anatomic images (brain CT and/or MRI) used in the interpretation of the VIZAMYL™ images as well as de-identified demographic information.

Exclusion Criteria:

• If informed consent is required by the local IEC, the subject (or representative) is not willing to consent to their de-identified images and other data being used in this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	Accuracy was estimated as 100 percent (%) *(number of true positives [TP] + number of true negatives [TN]) / (number of TP + number of TN + number of false positives [FP] + number of false negatives [FN]). The data presented are the point estimates representing percentage of accuracy, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.	Up to 1093 days
Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	Sensitivity was defined as 100%*number of TP / (number of TP + number of FN). The data presented are the point estimates representing percentage sensitivity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.	Up to 1093 days
Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	Specificity was defined as 100%*number of TN / (number of TN + number of FP). The data presented are the point estimates representing the percentage specificity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.	Up to 1093 days
Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	The PPV was defined as 100%*number of TP / (number of TP + number of FP). The data presented are the point estimates representing percentage PPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.	Up to 1093 days
Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	The NPV was defined as 100%*number of TN/ (number of TN + number of FN). The data presented are the point estimates representing percentage NPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.	Up to 1093 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Coefficient Between Clinical Reader Age and Accuracy	Correlation coefficient was used to assess the correlation between clinical reader age and accuracy. A scatterplot of clinical reader accuracy vs. reader age was plotted to check correlation (coefficient) between accuracy and age.	Up to 1093 days
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers	Number of participants with accuracy < 0.9333 or >= 0.9333 in terms of sex of clinical readers were reported.	Up to 1093 days
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy	Number of participants with association of electronic training (with or without In-person training) with clinical reader accuracy were reported.	Up to 1093 days
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy	Number of participants with association of In-person training (with or without electronic training) with clinical reader accuracy were reported.	Up to 1093 days
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)	Number of participants with association of training type with clinical reader accuracy (excluding readers who took both types) were reported.	Up to 1093 days
Time From Last Training	Time from last training was reported. Number of readers remaining at timepoint was number of readers with accuracy greater than or equal to 0.9333. All readers met this criterion at time 0 hence, data for all clinical reader is reported. All 18 readers were trained in interpretation of Vizamyl images & as part of their training, had their interpretation accuracy tested using 15 test images. To pass test, a reader had to interpret atleast 14 of 15 images correctly. 14 represents 0.9333 of 15, so each reader had to have an accuracy of atleast 0.9333 in order to pass test. Date on which a reader took his/her test is considered to be Time 0. Each reader's accuracy at a later time was assessed in study.	Retrospective data covering up to 8.1 years

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: ICON plc
• Investigators: Study Director: Paul Sherwin, MD, PhD, GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2018
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: dementia; Alzheimer's disease; cognitive impairment; Vizamyl; flutemetamol
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: GE-067-027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No