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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773015
• Other study ID #: GE-067-027
• Status: Completed
• Start date: December 11, 2018
• Est. completion date: December 7, 2021

Study information

• Verified date: July 2022
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Locations

Country	Name	City	State
Austria	Kepler Universittsklinikum Neuromed Campus	Linz	Wagner-Jauregg-Weg
Austria	Landeskrankenhaus Vocklabruck	Vöcklabruck
Finland	Helsinki University Central Hospital	Helsinki
Italy	Ospedal Mons Dimicolli - Barletta	Barletta
Italy	U.O. Medicina Nucleare- ASSST Spedali Civili P.O. di Brescia	Brescia
Italy	Azienda Ospedaliero Universitaria Careggi - S.O.D. Patologia Medica	Firenze
Netherlands	Catharina Ziekenhuis	Eindhoven
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Vall d'Hebron University Hospital	Barcelona
Spain	Clinica Universidad de Navarra	Pamplona

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	ICON plc

Countries where clinical trial is conducted

Austria,  Finland,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the diagnostic accuracy determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice	Diagnostic accuracy is defined as the (number of true positives + number of true negatives) / total number of evaluable images. The 95% exact binomial confidence interval of the accuracy estimate will also be provided.	Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes.
Primary	Determine the diagnostic sensitivity determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice	The sensitivity is defined as the number of true positives / (number of true positives + number of false negatives). The 95% exact binomial confidence interval of the sensitivity will also be provided.	Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes.
Primary	Determine the specificity determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice	The specificity is defined as the number of true negatives / (number of true negatives + number of false positives). The 95% exact binomial confidence interval of the specificity will also be provided.	Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes.
Primary	Determine the positive predictive value (PPV) determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice	The PPV is defined as the number of true positives / (number of true positives + number of false positives). The 95% exact binomial confidence interval of the specificity will also be provided.	Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes.
Primary	Determine the negative predictive value (NPV) determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice	The NPV is defined as the number of true negatives / (number of true negatives + number of false negatives). The 95% exact binomial confidence interval of the specificity will also be provided.	Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes.
Secondary	Evaluate the impact of demographic and other factors (such as method of training, gap between training and reading, and country) on diagnostic accuracy to try to identify factors that may be associated with image interpretation errors	Diagnostic accuracy, estimated as (number of true positives + number of true negatives) / total number of evaluable images, will be provided for different subgroups of demographic and other factors.	Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes.