Study Coordinator: Prof. Dr. Arnd Dörfler (AD)
Facharzt für Diagnostische Radiologie und Neuroradiologie
Universitätsklinikum Erlangen, Department of Neuroradiology
Study CRO: MEDIDATA GmbH
Contact: Dr. Thomas Plath
Director medical Imaging Services
Tel: 07531 94238-07, 030 66766746
Fax.: 07531 52782
Study Software Development: mediri GmbH
Contact: Dr. André Bongers
Tel: 06221 433388-13
Fax: 06221 433388-20
Data Receipt: mediri, MEDIDATA
Sites will be instructed to transfer images in DICOM format from all time points including subject demographic meta data via the web using the upload tool. Alternatively, as a back-up option only, images can be burned on DVDs and shipped via courier service.
In total, 200 MRI baseline time points are expected from all four sites. Follow-up time points are not expected and if received shall not be reviewed in the SAPP study.
Image Quality Check: AD, mediri
Completeness and quality of images will be checked in sub studies using an automatic query tool. Sites will receive acceptances when the data are acceptable or detailed queries for each time point when data are missing or unclear. Medical selection of relevant MR series, slices and views will be done prior to review preparation.
Preparation of perfusion images: AD, MEDIDATA
For each baseline timepoint/subject four parameter maps will be prepared. The images will be presented to the reader using MEDIDATA tracking, workflow tools and processes.
Perfusion Software: AD, mediri, MEDIDATA
Perfusion analysis will compare the outcome of several software products which are all hosted on MEDIDATA servers/remote servers: e.g. Nordic ice, Olea medical, Siemens syngo via, iCAD, PIViewer® (MEDIDATA software)
Charter development: MEDIDATA
The charter describes the qualitative and quantitative assessments, review workflow, presentations of images, usage of analysis software and completion of CRFs. Independent reads will be executed as single radiology review performed by at least one board certified radiologist experienced in perfusion analysis and the respective indications. It is anticipated to finalize and sign the charter after two rounds of revision.
CRF Development: AD, MEDIDATA
The outcome of the independent review will be documented on paper case report forms, completed and signed off by the reviewer with subsequent data management including query regime. Only subject identifiers maybe prefilled by MEDIDATA.
Conduct of Independent Central Read: MEDIDATA
Prior to assignment of subjects for independent read a data reconciliation between acquired study images at the four sub study sites and all received data at MEDIDATA should be executed. MEDIDATA will compare tracked image data with site listings (e.g. enrolment lists) off all MR scans. At least site and subject number, scan date and MR series should be reconciled. Presenting certain timepoints a second time to the reader (intra-variability assessment) is not planned.
The read will take place using MEDIDATAs IT infrastructure at a dedicated MEDIDATA review office.
Data management: MEDIDATA
The data management activities comprise the development of the data base, review of radiology paper CRFs, double data entry, review query management, subsequent data cleaning and export.
The statistical analysis includes SAS programming, editing, quality checks. Details are documented in the statistical analysis plan.
At study end all paper CRFs, study core documents and the data base will be archived and stored for 15 years at MEDIDATAs facility or at an external storage facility.
It is not intended to send raw images and reviewed images to the sponsor after study close-out.