1. 28th April 2008 What scans to perform for patients entered in IST3 and how to send them to the trial office Eleni Sakka Joanna Wardlaw Peter Sandercock

2. 28th April 2008 Outline When to perform scans –Before randomisation –24-48 hours post randomisation –If the patient has a neurological event within first 7 days Technical details of the scans –CT scans –MR scans Sending the scan to Edinburgh –The scan transfer form (compulsory) –Methods of sending the scan Eleni the Scan technician

3. 28th April 2008 ALL IST-3 patients should have a CT or MR brain scan Before randomisation to exclude: –intracranial haemorrhage –non stroke causes of the recent stroke-like symptoms. At 24-48 hours after randomisation irrespective of treatment allocation (i.e. patients allocated control as well as those allocated rt-PA). At other times within 7 days of randomisation, if –the patient deteriorates neurologically, –is suspected to have had either an intracranial haemorrhage or a recurrent ischaemic stroke

4. 28th April 2008 Technical details of the scans: initial set up for IST-3 Prior to starting recruitment in your centre, you must send a test scan to the trial office in Edinburgh. This must be the type of scan (CT, MR or both) that you intend to use in IST-3. The test scan is to : –check that the stroke imaging in your centre is OK for IST-3; –can be read by our software; –to chose which scan transfer mechanism suites you; –to iron out any unforeseen problems The test scan should be a typical scan as performed for stroke in your centre, but MUST meet the IST-3 scan requirements for CT or MR (see next slides) Approval to join the trial is based on the test scan type – if CT, then you are only approved for CT. You cannot introduce MR without sending a test MR scan first.

5. 28th April 2008 Technical details of the scans: CT Non-contrast Should cover the entire brain from the foramen magnum to the vertex, with maximum slice thickness: –4 – 5mm through the posterior fossa –8 – 10mm for the cerebral hemispheres, with no slice gap –Thinner slices from modern spiral scanners are OK. Scans should be windowed on –a width of 80 Hounsfield Units (HU) –A centre level of 35 – 40 HU.Correct windowing is particularly important if scans are to be sent as printed film Note we collect CT perfusion and angiography imaging if performed, but this is not essential for IST-3

6. 28th April 2008 Example of CT scan slices required

7. 28th April 2008 Technical details of the scans: MR MR brain imaging is allowed in place of CT only if there is sufficient radiological support in the hospital to interpret the scans. MR sequences must include axial: –a gradient echo (T2*) to exclude haemorrhage (haemorrhage can be overlooked on several other types of MR imaging sequence) –Diffusion Weighted Imaging (DWI) to identify the recent infarct. –FLAIR or T2-weighted sequences to show brain structure, white matter lesions, old infarcts. –Note: we collect perfusion and MR angiography imaging if performed, but this is not essential for IST-3

8. 28th April 2008 Technical details of the scans: MR MR sequences must include axial: Note: we collect perfusion and MR angiography imaging if performed, but this is not essential for IST-3. Gradient echo (T2*) DWI with ADC mapFLAIR or T2

9. 28th April 2008 Sending the scans to Edinburgh: please 1.Send the baseline and 24-48 hour follow-up scans (and any extra scans performed due to further events within 7 days) to the Edinburgh trials office, either by –electronic transfer of DICOM files (subject to certain conditions), or –other methods of electronic file transfer, or –post –If you send hard copy film, please make a copy and send us the original scan: we will return it*. 2.Complete and send a scan transfer form with each scan (compulsory), ie one form with the pre-randomisation and one form with the 24-48 hour scan 3.If sending MR scans, please check that you have sent all the sequences we require. 4.Full instructions on the six different methods of sending scans to Edinburgh are available in the Scan transfer SOP 1

10. 28th April 2008 Anonymising the scans All scans are fully anonymised before being added to the IST-3 database in Edinburgh However, if you need to anonymise the scans before sending them to Edinburgh, please substitute the patients IST-3 ID number for the patients name, either on the film, or if sending the files electronically, in the DICOM header name field. PLEASE make sure that the scan transfer form is correctly and completely filled in!

11. 28th April 2008 Frequently asked questions Q: The patient also had a perfusion scan, should I send that as well? –A: YES. But indicate this on the scan transfer form PLEASE! Q: We weren’t able to perform a post -randomisation scan within the time limit of 48 hrs that is specified by the IST3 guidelines –A: We do accept post-randomisation scans that took place after the limit of 48hrs, in cases that it was impossible to perform a scan earlier. PLEASE note this on the scan transfer form, otherwise we will need to issue a query, which will delay the analysis of the scans. Q: I am having trouble anonymising the scan before sending it. –A: please contact Eleni Sakka, the IST-3 imaging technician to advise how best to do this. Eleni.Sakka@ed.ac.uk

12. 28th April 2008 Eleni Sakka Role: IST-3 scan data manager Contact details email: eleni.sakka@ed.ac.ukeleni.sakka@ed.ac.uk Please contact Eleni in the first instance with scan related queries – she will refer these to the appropriate source where necessary.

13. 28th April 2008 Full details of all procedures are available at: www.ist3.com