WP 08: Imaging Study

Objectives

  1. To manage all central collection of EuroHYP-1 image data and provide expert neuroradiological review of pre-randomisation imaging (CT or MRI) to: (1) ensure that patients with radiological evidence of alternative diagnoses are not included (and related quality assurance purposes), and where they have been included to provide appropriate feedback to recruiting centres; and (2) to characterise included patients by classifying the presence, pattern, and volume of the acute ischaemic changes and any old stroke-related or aging-related tissue changes present on initial imaging.
  2. To assess patient responses to hypothermia by measuring structural lesion outcome on follow-up imaging, to allow a comparison of the effect of hypothermia on early structural (infarct growth/extent, swelling, haemorrhagic transformation) and late functional outcome to inform the use of hypothermia in future clinical practice.
  3. To provide a platform to manage image data associated with planned sub studies (to be funded from external sources) such as studies of the effectiveness of cooling on normal and ischaemic brain temperature using Magnetic Resonance spectroscopic thermography, or of the role that CT or MR perfusion or angiography imaging may play in identifying patients who may benefit from therapeutic hypothermia.

Work package Description

WP 8 is led by Prof. Joanna M Wardlaw (University of Edinburgh, UEDIN) and Prof. Rüdiger von Kummer (University of Dresden, TUD), who have extensive experience of managing imaging assessment in large multicentre stroke treatment trials.

Task 1: Define image acquisition (M01-03).Define the minimum essential image acquisition requirements for structural CT and MR image data, angiography and perfusion. Minimum CT data will include a volume CT brain scan and axial reconstructions on 1.5 and 6mmslice thickness and MR sequences include DWI, FLAIR, GRE.
Responsible: JMW (UEDIN), RvK (TUD).

Task 2: Establish minimum imaging requirements for centre validation and quality assurance to ensure high quality image data (M01-03).Each centre will be requested to send a test scans during start up. Centres will only be approved for the scan type that was approved during start up. This enables imaging quality assurance.
Responsible: JMW and RvK.

Task 3: Image data submission mechanisms (M02-05).We will use a modified version of the image data submission developed for the Third International Stroke Trial which supports five different electronic and one film method of image data transfer and address the individual country data protection regulations and variation in imaging technologies available.
Responsible: JMW, DP.

Task 4: Link the image management database to the central trial patient database for data security and housekeeping to ensure high quality complete data (M03-05).
Responsible: JMW, MMcL, DP.

Task 5: Establish a robust, blinded imaging assessment IT-platform, enabling the easy and efficient transfer of the data between the various IT-platforms and a pan-European, standardized effort for the interpretation and analysis of the results (M02-06).Adapt the Systematic Image Review System (SIRS) image viewing and quantification method developed forIST3 (www.neuroimage.co.uk/sirs).
Responsible: JMW, D Perry, Centre managers.

Task 6: Design, test and implement image rating data collection form (M03-06) to assess the index stroke lesion at baseline and 5 day follow-up. Secondary lesion volume measurements will be centrally.
Responsible: JMW and RvK.

Task 7: Perform image rating in a timely fashion - images will be distributed through worklists equally to raters via the SIRS central scan management system.
Responsible: JMW and RvK.

Task 8: Monitor the imaging data interpretation effort – apply an advanced, specific, written quality assurance method.
Responsible: JMW and RvK.

Task 9: Support of sub studies: The Imaging WP will provide support to externally funded sub studies including for instance those relating to CT Perfusion and MR thermography (Levi).

Task 10: Data analysis: This will be conducted in collaboration with the Statistical WP.