Leader: eppdata – Jens Fiehler
WP3 comprises the image core lab and central reading of all images acquired in the trial. The objectives are:
- Monitor and ensure the highest quality level of image acquisition and judgement in all trial centres
- Ensure the safety of patients treated in the clinical trial
- Ensure enrolment of the pre-specified target population into the clinical trial
- Provide reference judgements for secondary efficacy and safety endpoints (infarct volume, intracerebral haemorrhage)
- Define populations for per protocol analysis and for image based subgroup analysis
TENSION will test the efficacy and safety of thrombectomy in patients with extended stroke lesions defined by an ASPECT score of 3-5. Thus, the highest quality of acquisition and analysis of CT and MR images as well as image judgement conforming to the selection criteria defined in the trial protocol are of major importance for the success of the clinical trial. This will be guaranteed by WP5. Experienced Neuroradiologists with long-standing expertise in acute stroke image reading within clinical trials will constitute a core image lab and perform and centrally review all images acquired within the clinical trial. Central image reading will include the continuous monitoring of appropriate quality of image acquisition and interpretation in the trial sites as specified together with WP2 (Training and standards), the identification and classification of intracerebral haemorrhages representing primary and secondary safety endpoints of the clinical trial, the reference, the classification of all pre-randomisation CT and MR images in terms of imaging inclusion and exclusion criteria as specified in the trial protocol, thus checking the quality of on-site image judgement and defining a target population for per protocol analysis. Finally, infarct volume will be measured representing a secondary endpoint.
WP3 is led and organized by eppdata, an SME providing comprehensive solutions to image data management with strong support from the department of neuroradiology at Universitätsklinikum Hamburg-Eppendorf. The experienced Neuroradiologists from Universitätsklinikum Hamburg-Eppendorf and Universitätsklinikum Heidelberg have already proven effective cooperation in previous clinical stroke trials and investigator initiated cooperative projects. To enable the activities in WP3, an image database will be created and maintained to collect and administrate all brain images acquired in the trial. A workflow for central image reading will be established, and an algorithm will be developed to respond to relevant findings from central image reading. The WP is expected to be active 9 months beyond the completion of patient enrolment to allow for answering possible questions occurring as to central image reading even after completion of patient enrolment.