Clinical trial NCT04773015: A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe
Official title: A Post-Authorisation Safety Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Keywords: Vizamyl
flutemetamol
Alzheimer's disease
cognitive impairment
dementia
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2021-02-26
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary referral

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
timeFrame: Up to 1093 days
measure: Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
timeFrame: Up to 1093 days
measure: Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
timeFrame: Up to 1093 days
measure: Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
timeFrame: Up to 1093 days
measure: Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
timeFrame: Up to 1093 days
Secondary outcomes:
measure: Correlation Coefficient Between Clinical Reader Age and Accuracy
timeFrame: Up to 1093 days
measure: Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers
timeFrame: Up to 1093 days
measure: Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy
timeFrame: Up to 1093 days
measure: Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy
timeFrame: Up to 1093 days
measure: Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)
timeFrame: Up to 1093 days
measure: Time From Last Training
timeFrame: Retrospective data covering up to 8.1 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universittsklinikum Neuromed Campus
state: Wagner-Jauregg-Weg
city: Vöcklabruck
country: Austria
facility: Landeskrankenhaus Vocklabruck
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Barletta
country: Italy
facility: Ospedal Mons Dimicolli - Barletta
city: Brescia
country: Italy
facility: U.O. Medicina Nucleare- ASSST Spedali Civili P.O. di Brescia
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi - S.O.D. Patologia Medica
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
Study officials:
affiliation: GE Healthcare
name: Paul Sherwin, MD, PhD
role: STUDY_DIRECTOR
References: