TECHNICAL SURVEY Dear Investigators, This document is a Technical Survey which provides the teams of THERALYS and of the Pierre Wertheimer Neurological Hospital of Lyon with an overview of your site s imaging context. During this Study, each patient will have: One MRI scan performed at randomization visit, which takes place at the 6 th week of amenorrhea. This scan taking place during pregnancy, it will therefore be done without Gadolinium. Four post-delivery MRI scans performed at weeks: W4, W8, W12 and W24 post delivery. The following MRI sequences (with a slice thickness of mm, acquired parallelly to the ) will be available for each study: Proton Density (PD) and T2-weighted FLAIR Diffusion T1-weighted T1-weighted after a Gadolinium injection, only at W4, W8, W12 and W24 THERALYS will ensure that the image acquisition procedure implemented at your site complies with the Study s MRI protocol. The quality of the MRI scans will have a major impact on the overall quality of the Study. Please complete this Technical Survey and send it back to THERALYS either by fax using the following fax number: +.()4.26.2.5.6 or by filling this electronic document and by emailing it back to: popartmus@theralys.com Should you have any question or comment regarding this survey or related to the imaging component of the POPARTMUS Study in general, please do not hesitate to contact us: Luc BRACOUD - Projet Manager : lbracoud@theralys.com Tel: +.()4.26.2.5.5 : +.()4.26.2.5.6 Please note that to contact the THERALYS team, the following email address can also be used: : popartmus@theralys.com We thank you very much in advance for your precious collaboration and are looking forward to meeting you soon. THERALYS team. Abbreviations used in this document: AC-PC Anterior Commissure Posterior Commissure FTP File Transfer Protocol ADC Apparent Diffusion Coefficient Left-Right AP Anterior-Posterior NEX Number of Excitations DICOM Digital Imaging and Communications in Medicine NSA Number of Signal Averages EPI Echo Planar Imaging PD Proton Density FLAIR FLuid Attenuated Inversion Recovery SE Spin Echo FOV Field Of View TSE Turbo Spin Echo FSE Fast Spin Echo Page 1 of 5 THERALYS - Bioparc, 6 avenue Rockefeller - 698 Lyon - France : +.()4.26.2.5.5 - : +.()4.26.2.5.6 - : popartmus@theralys.com POPARTMUS-25-2 EN 2.2
TECHNICAL SURVEY Clinical site City / Institution :.. Survey completed by: Date: MRI system Manufacturer:... Model: Version:. Can your MRI system export data in DICOM format on CDROMs? Are you able and willing to transfer the image data via File Transfer Protocol (FTP)? What storage medium is used by your site for onsite archiving of MRI data? Coil Manufacturer : Type:.. Gadolinium Injection Contrast agent used:.. Concentration :.. Type of injection (automatic / manual) and rate:... Diffusion sequence THERALYS will systematically generate Apparent Diffusion Coefficient (ADC) and Mean Diffusivity ( Trace ) maps from native diffusion-weighted images. Can your MRI system export directional images of the diffusion sequence (b images + b~1 s/mm 2 images per slice, that is to say 4 image series): Can your MRI system export ADC parametric maps? Can your MRI system export MD ( Trace ) parametric maps? Page 2 of 5 THERALYS - Bioparc, 6 avenue Rockefeller - 698 Lyon - France : +.()4.26.2.5.5 - : +.()4.26.2.5.6 - : popartmus@theralys.com POPARTMUS-25-2 EN 2.2
Etude POPART MUS - - TECHNICAL SURVEY Clinical site City / Institution: The following table provides a common basis of acquisition parameters for all sites. The other parameters will be finalized depending on the manufacturer and model of your MRI system, following your answer to this survey. In the lower right part of each cell are indicated the values requested by the MRI protocol. Please confirm that you can fulfil these requirements. Comments: Orientation Number of slices Slice thickness (mm) Slice gap (mm) FOV (mm) Rect. FOV (%) Acquisition Matrix Number of acquisitions (NSA or NEX) Phase encoding direction Specific settings PD / T2 T1 and T1 Gado FLAIR Diffusion 4 1 FSE / TSE 4 1 SE 4 2 4 1% 128 2 AP SE EPI b= et b=1 s/mm 2 directions Exportation of directional images Please see that full brain coverage is achieved for each sequence The acquisition will be parallel to the for all the sequences of the protocol The T1-weitghed sequence with Gadolinium injection will be the last to be performed, 5 minutes following the injection. The same contrast agent must be used for all the studies of a given patient Your comments: Page of 5 THERALYS - Bioparc, 6 avenue Rockefeller - 698 Lyon - France : +.()4.26.2.5.5 - : +.()4.26.2.5.6 - : popartmus@theralys.com POPARTMUS-25-2 EN 2.2
CONTACT LIST Clinical site City / Institution: You may want us to contact other neuroradiologists or imaging technologists from your site. In such case, please use the following contact sheet to provide us with their contact information. Page 4 of 5 THERALYS - Bioparc, 6 avenue Rockefeller - 698 Lyon - France : +.()4.26.2.5.5 - : +.()4.26.2.5.6 - : popartmus@theralys.com POPARTMUS-25-2 EN 2.2
CONTACT LIST Clinical site City / Institution: Page 5 of 5 THERALYS - Bioparc, 6 avenue Rockefeller - 698 Lyon - France : +.()4.26.2.5.5 - : +.()4.26.2.5.6 - : popartmus@theralys.com POPARTMUS-25-2 EN 2.2