A prospective observational study to assess effectiveness of the training and risk minimisation measures recommended for the usage of the diagnostic agent NeuraCeqTM in the post-authorisation clinical situation: A post-authorisation safety study (PASS)

Study identification

• EU PAS number:
  EUPAS12145
• Study ID:
  39964
• Official title and acronym:
  A prospective observational study to assess effectiveness of the training and risk minimisation measures recommended for the usage of the diagnostic agent NeuraCeqTM in the post-authorisation clinical situation: A post-authorisation safety study (PASS)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  Study to monitor the frequency of reading errors of Florbetaben (18F) PET scan images after completion of NeuraCeq PET scan reading training. Participating Nuclear medicine physicians will be asked to take a test assessment consisting of 20 Neuraceq PET cases including positive and negative cases. These test cases are presented immediately after the reader training as well as 6 months later. The test scans will include cases with histopathology confirmation of the diagnosis, and longitudinal clinical data in MCI subjects, as well as scans from young cognitively normal healthy volunteers. Test scan assessments will be matched against scan read outs made by 2 independent experts, who agreed on the scan report as positive or negative. Study on effectiveness of risk minimisation measures as recommended in the NeuraCeqTM RMP to be assessed for the same 100 nuclear medicine physicians who underwent reader training and agreed to participate in the study. Effectiveness of the risk minimisation measure is based on results of a questionnaire, which evaluates compliance with the recommended risk minimisation measures. The Nuclear Medicine physicians will populate the questionnaire twice, first immediately after inclusion into the study and again 6 months later. If scan reader training has been performed more than one month before study inclusion, label information will be retrained.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:15/12/2015

Study start date

Planned:31/03/2016

Actual:24/03/2016

Data analysis start date

Planned:15/03/2017

Actual:01/06/2017

Date of interim report, if expected

Planned:30/06/2017

Actual:28/06/2017

Date of final study report

Planned:29/03/2019

Actual:01/02/2019

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)