Post-Authorisation Survey of Nuclear Medicine Physicians and Radiologists in Europe to Evaluate Trends and Patterns in VIZAMYL™ Use in Everyday Clinical Practice in the EU

Study identification

• EU PAS number:
  EUPAS25167
• Study ID:
  26712
• Official title and acronym:
  Post-Authorisation Survey of Nuclear Medicine Physicians and Radiologists in Europe to Evaluate Trends and Patterns in VIZAMYL™ Use in Everyday Clinical Practice in the EU
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Finland

  Germany

  Italy

  Slovakia

  Sweden
• Study description:
  This drug utilisation study, is designed in response to request from EMA, will retrospectively assess the actual use of VIZAMYL PET scans in the everyday clinical settings and determine the level of off-label use in Europe. The study will retrospectively survey VIZAMYL readers in European countries where VIZAMYL is commercially available and where high use is expected during the study period to determine trends and patterns of VIZAMYL use in everyday clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:03/12/2018

Actual:12/03/2018

Study start date

Planned:12/02/2019

Actual:01/07/2020

Date of final study report

Planned:20/08/2020

Actual:29/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GE HealthCare

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable