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Centralized Imaging Services

H. LUNDBECK A/S Stroke - Desmoteplase DIAS-4 Investigators’ Meeting, Chicago , July, 2011 Presented by Thomas Truelsen, Lundbeck. Centralized Imaging Services. DIAS-4 Study Imaging summary 1/2. DIAS-4 Study Imaging summary 2/2.

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Centralized Imaging Services

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  1. H. LUNDBECK A/S Stroke - Desmoteplase DIAS-4 Investigators’ Meeting, Chicago , July, 2011 Presented by Thomas Truelsen, Lundbeck Centralized Imaging Services

  2. DIAS-4 Study Imaging summary 1/2

  3. DIAS-4 Study Imaging summary 2/2

  4. Start up phase Running phase of the study of the study Image Quality Control DIAS-4 Study Imaging Worflow Image Collection & Initial Check Study supplies Site Phone Training Central Reading Organization Site Imaging Evaluation Data transfer to sponsor Query Management

  5. Site Imaging Evaluation (1/6):Purpose For Synarc: • Verify the ability of each site to acquire images according to the requirements described in the Imaging Manual and the MR & CT Procedure Manual • Verify the readibility of the images in Synarc Imaging software (DICOM format) For the site: • Sites are encouraged to record the DIAS-4 study specific parameters in the device(s) (according to settings pre-defined in the Imaging Manual). • These parameters are not mandatory any more, however, in order to standardize the imaging procedure study sites are highly recommended to stick to them.

  6. Site Imaging Evaluation (2/6):Workflow Initial site selection questionnaire LUNDBECK new imaging survey 1 2 Investigator Site Filled in questionnaires 3 Qualification Notification SYNARC 4 Imaging package shipment

  7. Site Imaging Evaluation (3/6): • Before study start each study site should fill in an imaging survey with data on potential CT or MRI scanners to be used in this trial • E.g. brand, software, availability of DICOM standard, availability of DICOM saving, etc.. • Phantom scans no longer needed • Each survey can be filled in with information for 3 CT and 3 MRI scanners • Already qualified scanners do not need to be entered in the survey • The forms should be sent via email to Jamal Smyej JSYM@lundbeck.com • After evaluation the study site will receive an email notification from the imaging lab Synarc

  8. Site Imaging Evaluation (4/6):Site supplies • Evaluation survey: • Provided to the site once site has been selected for the trial • Complete supply package: • Provided to the sites once evaluation completed • to perform exam acquisitions all along the study: • Imaging Binder containing Imaging Manual and Procedure Manual • triplicate Transmittal Forms and pre-labelled CD-ROMs • Courier shipping material (UPS) • One acknowledgement of receipt to be faxed back to Synarc upon package receipt

  9. Site Imaging Evaluation (5/6):MR&CT Imaging Procedure Manual • Document which summarizes imaging protocol and data handling • All personnel involved in the imaging part of the trial (Neuroradiologist, Technologist, Study Coordinator) need to read and fully understand the Imaging Manual • And to sign Page i of the Imaging Procedure Manual • Please fax a copy of this completed page to Synarc San Francisco • Keep original in the procedure manual

  10. Site Imaging Evaluation (6/6):Remote Site Phone Training • Purpose: Logistical Training provided by Synarc to site (by phone). It is organized once complete supply package has been received and has to be followed by the MRI and/or CT technologist and the study site Coordinator. • Content: • Presentation of the study material and documents • Image acquisition details • Image and exam identification • Package preparation and shipment (FedEx) • Data Clarification Form • For information: Additionally to the Synarc phone training, one web-based training will be coordinated and organized by Lundbeck to provide information regarding eligibility criteria .

  11. Image acquisition and collection (1/6) :Image flow Store images on the CD-ROM. Fill in the patient/visit information on the CD-ROM Images should be sent to SYNARC within 2 days of acquisition Place the Transmittal Form (original) and the labeled CD-ROM in the padded envelope A copy of all images must be kept at site Images to be shipped to SYNARC via courier Fill in the Transmittal Form, Fax it to SYNARC San Francisco Keep yellow and pink copies at site.

  12. Image acquisition and collection (2/6)electronical data transfer • A new option has been agreed on with Synarc to replace shipment of physical films by an FTP transfer • This change should not be forced on to sites as mandatory – but rather implemented where the sites think this could be an advantage • A short feasibility questionnaire need to be sent to the sites to check for compatibility • The CRAs will be asked to send the FQ to the sites and feedback the results of the discussions to Lundbeck and Synarc

  13. Image acquisition and collection (3/6) : Expected exams/sequences

  14. Image acquisition and collection (4/6) :Image Labeling • Main information needed for images identification: • Study patient number • Date of Birth • Acquisition date • Visit code • Please be careful to anonymize/de-identify the images for legal reasons • Make sure to enter the cerebral hemisphere side affected by the acute stroke in the image. Same information has to be present on transmittal form and within the images.

  15. Image acquisition and collection (5/6) : Transmittal Forms

  16. 02-JAN-2006 Image acquisition and collection (6/6):Transmittal Forms Error-MMS 03JUN06 JUN Filling the Transmittal Forms Contains the description of the images sent (to be filled-in according to the GCP guidelines): • Patient and visit information • Image acquisition (series number burnt on the CD-ROM) • Air waybill number • Name and signature of Technologist • Form to be faxed to Synarc before shipment of the entire data package Good Clinical Practices • Use black or blue ink • Write clearly and legibly • Correct mistakes properly (strike through error, put initials and date next to correction) • Do NOT use correction fluid • Fill out the forms properly • Use the labels provided for CD’s • Include proper signatures • Maintain subject and clinical protocol confidentiality • Contact SYNARC for any questions/problems

  17. Image Quality Control (1/2) • Presence and readability of all documents (first check) • Presence of all the documents per visit (transmittal form and CD) • Verification of the readability of the documents (images format) • Anonymity • If images not anonymised yet: anonymisation done by SYNARC • Patient identity / Date of Acquisition of the scan • Proper labeling of the images in accordance with the transmittal form information (patient and visit information) • Complete scan • Compliance to the imaging protocol and presence of sequences required by the protocol • Imaging parameters • Presence of the information required for the quantitative evaluation (slice thickness, …)

  18. Image Quality Control (2/2): Query Management • Query Management: • In case of missing information, missing image, discrepancy between the information … •  SYNARC will send a Data Clarification Form by email to the site •  The site will have to send back the Data Clarification Form filled by fax and if necessary with other documents

  19. Investigator’s center Central Reading (1/3):Eligibility Reading SYNARC QC, Anonymization Randomization Feedbackto sponsor IP Network Inclusion /exclusion criteria Inclusion /exclusion criteria Inclusion /exclusion criteria Imaging Committee Workstations Io Workstation Io Workstation Io Workstation

  20. Central Reading (2/3):Safety and vessel status Reading • Safety Reading: • Central Reading pannel to assess the presence of Hemorrhage and/or Ischemic Oedema • Vessel status and recanalization Reading: • Central Reading pannel to assess the vessel status from baseline and 12-24h follow-up images

  21. Volume of the lesion ROIs delineated on the images Central Reading (3/3):Quantitative Assessment • Central Reading pannel to assess infarct volume • Validation or correction of the ROIs by the central Reader of the Imaging Committee • Automatic calculation of the volume using the imaging lab reading workstation (using information from DICOM header (slice thickness, slice position…)

  22. Staying in touch • Clemence Blondeau Project Manager at Synarc clemence.blondeau@synarc.com • Jamal Smyej Imaging specialist at Lundbcek jsmy@lundbeck.com Synarc Inc. 7707 Gateway Boulevard Bldg 5, 3rd Floor Newark, CA 94560 USA

  23. Thank you! Any questions?

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