American company conducts a study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe
GE Healthcare is recruiting patients for the clinical trial of 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
December 11, 2018 is the study start date. The indicative completion of the clinical trial will be expected in March 2021.
Among primary outcome measures are the 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 and 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.
The study will take place at the Kepler Universittsklinikum Neuromed Campus, Linz, Wagner-Jauregg-Weg, Austria; Landeskrankenhaus Vocklabruck, Vöcklabruck, Austria; Helsinki University Central Hospital, Helsinki, Finland; 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, Italy; Catharina Ziekenhuis, Eindhoven, Netherlands; Vall d'Hebron University Hospital, Barcelona, Spain; Hospital Universitari de Bellvitge, Barcelona, Spain and Clinica Universidad de Navarra, Pamplona, Spain.
There are a number of conditions that allow participation, such as:
- The participant 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 participant, 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.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04773015
