Status:
COMPLETED
A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
ICON plc
Conditions:
Cognitive Impairment
Eligibility:
All Genders
18+ years
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
- 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
- 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.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT04773015
Start Date
December 11 2018
End Date
December 7 2021
Last Update
October 10 2024
Active Locations (10)
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1
Kepler Universittsklinikum Neuromed Campus
Linz, Wagner-Jauregg-Weg, Austria, 4020
2
Landeskrankenhaus Vocklabruck
Vöcklabruck, Austria, 4840
3
Helsinki University Central Hospital
Helsinki, Finland, 00209
4
Ospedal Mons Dimicolli - Barletta
Barletta, Italy, 70051