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

Completed

• Conditions: Cognitive Impairment

• Registration Number: NCT04773015
• Lead Sponsor: GE Healthcare

Brief Summary

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

Detailed Description

This study is a combination of Prospective and Retrospective models.

Study Timeline

• Study Start: 2018-12-11
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-26
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Results First Submitted: 2022-12-06
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Results First Posted: 2024-10-10
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	Up to 1093 days	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.
Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	Up to 1093 days	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.
Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	Up to 1093 days	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.
Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	Up to 1093 days	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.
Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers	Up to 1093 days	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.

Secondary Outcome Measures

Name	Time	Method
Correlation Coefficient Between Clinical Reader Age and Accuracy	Up to 1093 days	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.
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers	Up to 1093 days	Number of participants with accuracy \< 0.9333 or \>= 0.9333 in terms of sex of clinical readers were reported.
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy	Up to 1093 days	Number of participants with association of electronic training (with or without In-person training) with clinical reader accuracy were reported.
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy	Up to 1093 days	Number of participants with association of In-person training (with or without electronic training) with clinical reader accuracy were reported.
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)	Up to 1093 days	Number of participants with association of training type with clinical reader accuracy (excluding readers who took both types) were reported.
Time From Last Training	Retrospective data covering up to 8.1 years	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.

Trial Locations

Locations (10)

Ospedal Mons Dimicolli - Barletta; 🇮🇹 Barletta, Italy

U.O. Medicina Nucleare- ASSST Spedali Civili P.O. di Brescia; 🇮🇹 Brescia, Italy

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Azienda Ospedaliero Universitaria Careggi - S.O.D. Patologia Medica; 🇮🇹 Firenze, Italy

Kepler Universittsklinikum Neuromed Campus; 🇦🇹 Linz, Wagner-Jauregg-Weg, Austria

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Landeskrankenhaus Vocklabruck; 🇦🇹 Vöcklabruck, Austria