Pattern of use, safety and tolerability of the diagnostic agent NeuraCeqTM in European clinical practice: A cross-sectional, retrospective, non-interventional post-authorisation safety study (PASS) (FBB-01_03_13)

Study identification

• EU PAS number:
  EUPAS13366
• Study ID:
  39896
• Official title and acronym:
  Pattern of use, safety and tolerability of the diagnostic agent NeuraCeqTM in European clinical practice: A cross-sectional, retrospective, non-interventional post-authorisation safety study (PASS) (FBB-01_03_13)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  Cross-sectional, non-interventional retrospective survey of physicians who have referred at least one patient for a clinical NeuraCeqTM PET scan in European countries where the radiopharmaceutical is commercially available. Collection of study data can be conducted using a paper-based questionnaire. The survey will be conducted in countries with a large population including Italy, France, Germany, Spain and United Kingdom. These countries become eligible for study participation once at least 10 Neuraceq doses have been applied clinically. The individual referring site becomes eligible if at least one scan has been ordered for the evaluation of a patient in a clinical practice setting. Enrollment will commence once a country becomes eligible for study participation and an individual prescriber has at least sent one referral for NeuraCeqTM PET scan. The study will continue for 3 years or a target enrollment of 400 patients and 100 physicians. Upon a twice-yearly recruitment analyses in the first two years, survey participation may be adapted. Additional countries meeting inclusion criteria may be added to support minimal survey enrollment (defined as obtaining at least 100 patient reports from at least 20 referring physicians).
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:16/03/2016

Study start date

Planned:31/10/2016

Actual:21/12/2016

Data analysis start date

Planned:31/01/2017

Actual:01/11/2017

Date of interim report, if expected

Planned:30/12/2016

Actual:30/12/2017

Date of final study report

Planned:30/09/2020

Actual:03/09/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Piramal Imaging Ltd.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)