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Completed

NCT Number: NCT04773015

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kepler Universittsklinikum Neuromed Campus, Linz, Wagner-Jauregg-Weg, Austria

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About this study

This study is a combination of Prospective and Retrospective models.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers

    Time frame: 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.

  2. Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers

    Time frame: 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.

  3. Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers

    Time frame: 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.

  4. Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers

    Time frame: 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.

  5. Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers

    Time frame: 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 outcomes

  1. Correlation Coefficient Between Clinical Reader Age and Accuracy

    Time frame: 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.

  2. Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers

    Time frame: Up to 1093 days

    Number of participants with accuracy < 0.9333 or >= 0.9333 in terms of sex of clinical readers were reported.

  3. Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy

    Time frame: Up to 1093 days

    Number of participants with association of electronic training (with or without In-person training) with clinical reader accuracy were reported.

  4. Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy

    Time frame: Up to 1093 days

    Number of participants with association of In-person training (with or without electronic training) with clinical reader accuracy were reported.

  5. Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)

    Time frame: Up to 1093 days

    Number of participants with association of training type with clinical reader accuracy (excluding readers who took both types) were reported.

  6. Time From Last Training

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • ICON plc

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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