WP05 - Central image reading

This WP will comprise central image reading. The objectives of this WP are:

  • Monitor and ensure the highest quality level of image acquisition and judgement in all recruiting centres in the clinical trial
  • Ensure the safety of patients treated in the clinical trial
  • Ensure the inclusion of the pre-specified target population into the clinical trial
  • Define a population for per protocol analysis

The WP will be lead by participant 04 (S. Pedraza, IDIBGi), who has a long-standing experience as a member of image reading boards in clinical stroke trials. Experienced neuroradiologists from other partners (UKE, CharitÚ, KUL), who have already proven effective cooperation in previous collaborative projects including clinical stroke trials (e.g. DIAS-2) or investigator initiated cooperative projects (e.g. I-Know), will join the central image reading board.

A central image reading board will be established headed by the WP leader, joining experienced neuroradiologists from other participants (together with WP01). A web-based image processing and analysis system provided by participant 10 (mediri) will enable continuous web-based image reading for all participants and timely indication of relevant imaging findings (safety imaging endpoints or protocol violations) to the DSMB (together with WP01, 02, 03, 04). All images acquired within the WAKE-UP clinical trial will be continuously reviewed by members of the central image reading board (web-based). Protocol violations and safety endpoints will be identified and indicated to the DSMB and to the central data bank (see also Tasks 2 to 4). Regular meetings will be held in order to achieve consensus in borderline findings.

A qualitative assessment CRF will be developed to be completed for each set of images including 1) quality of sequences; 2) fulfilment of imaging inclusion criteria; 3) fulfilment of any exclusion criterion; 4) final decision: patient to be enrolled or not; 5) presence and classification of ICH.

This WP will be led by participant 04 (S Pedraza, IDIBGI). The WP will be active during months 01-60.

Participants involved in WP05: