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

NCT04773015 | Completed Results

• 1 other identifier: GE-067-027
• Study Type: observational
• Target: 227
• Locations: 5 countries
• Sites: 10

Brief Summary

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

Conditions

Cognitive Impairment

Keywords

Vizamyl; flutemetamol; Alzheimer's disease; cognitive impairment; dementia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Correlation Coefficient Between Clinical Reader Age and Accuracy

  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

  Up to 1093 days

• 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 In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy

  Up to 1093 days

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

  Up to 1093 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

tertiary referral

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• ICON plc: collaborator

Study Sites (10)

Kepler Universittsklinikum Neuromed Campus

Linz, Wagner-Jauregg-Weg, 4020, Austria

Location

Landeskrankenhaus Vocklabruck

Vöcklabruck, 4840, Austria

Location

Helsinki University Central Hospital

Helsinki, 00209, Finland

Location

Ospedal Mons Dimicolli - Barletta

Barletta, 70051, Italy

Location

U.O. Medicina Nucleare- ASSST Spedali Civili P.O. di Brescia

Brescia, 25123, Italy

Location

Azienda Ospedaliero Universitaria Careggi - S.O.D. Patologia Medica

Florence, 50134, Italy

Location

Catharina Ziekenhuis

Eindhoven, 5623, Netherlands

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Paul Sherwin, MD, PhD
• Organization: GE Healthcare

PaulSherwin@ge.com

609 510 3686

Study Officials

• Paul Sherwin, MD, PhD

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: December 11, 2018
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); NL (1); FI (1); ES (3); AU (2)