Enabling Centralised MRI Review through Secure Image Exchange
Client
Department of Radiation Oncology and Neurosurgery, University Medical Centre Mannheim, Germany. In cooperation with the imaging CRO Medwave Clinical Research B.V., Harlingen, Netherlands.
Project
Glioblastoma multiforme (GBM) is the most aggressive primary brain tumour in adults. Even after maximal surgical resection followed by radiochemotherapy, most patients experience tumour recurrence.
INTRAGO-II was an open-label, multicentre, randomised Phase III Trial. It investigated whether adding intraoperative radiotherapy (IORT) to the standard of care improves progression-free survival in patients with newly diagnosed, resectable glioblastoma.
The study enrolled 314 patients across 18 hospitals in seven countries. The primary endpoint, progression-free survival, was assessed using quarterly MRI examinations and a masked independent central imaging review (ICIR) according to modified RANO criteria, including perfusion imaging.
Challenge
Evaluating glioblastoma progression is highly complex. Treatment-related changes, including pseudoprogression and radiation necrosis, can closely resemble true tumour progression. Independent central review was, therefore, fundamental to the scientific integrity of the trial. Every MRI needed to reach the reviewers quickly, securely and in a standardised format, while preserving the blinded review process.
Over the lifetime of the study, this required:
- fast and reliable exchange of large DICOM datasets between 18 international hospitals and the CoreLab;
- regulatory compliance with GDPR and 21 CFR Part 11;
- efficient quality control before images entered central review;
- rapid communication whenever image quality or completeness requires clarification;
- close collaboration between investigators, project managers and central reviewers; and
- a workflow that could sustain consistent performance across more than a decade of trial execution.
Solution
The University Medical Centre Mannheim selected ClinFlows’ web-based platform, decidemedical, to serve as the imaging collaboration backbone for the trial.
Participating hospitals uploaded MRI examinations through a secure web interface. Automatic notifications alerted the central review team as soon as new studies became available, allowing quality control to begin without delay. Using the platform’s integrated DICOM preview function (SmartUploader), readers could verify image completeness and quality immediately on upload.
When additional sequences were required or technical issues were identified, decidemedical’s integrated discussion blog and query management tool enabled direct communication with participating sites, keeping every imaging-related correspondence linked to its case record and eliminating the delays typical of fragmented email communication.
Imaging CRAs at Medwave monitored imaging progress in real-time through dedicated oversight dashboards, allowing them to identify bottlenecks early and keep the study on schedule across all 18 sites.
Following quality control, Medwave’s independent neuroradiologists performed central reading using advanced neuroimaging analysis software (mint Lesions, Olea Medical). Completed expert reports were securely returned to the sites and the coordinating centre through the same platform, creating a single, traceable imaging workflow from acquisition to final assessment.
Result
Over 10 years of trial execution, 1,896 MRI examinations were exchanged through decidemedical, comprising 346 baseline and 1,550 follow-up scans, across 18 hospitals in seven countries.
decidemedical functioned as the single point of coordination connecting researchers at participating sites, imaging CRAs and the independent central review team. It sustained a consistent, uninterrupted imaging workflow across the full duration of a long-running, multinational Phase III trial without disruption to the blinded review process.
“Ten years have passed quickly. decidemedical’s flexibility to support INTRAGO-II’s specific needs, the platform’s robustness, and ClinFlow’s proactive approach with quick support whenever needed helped us greatly to keep the study on track. Let’s add another 10 years for a pleasant and fruitful cooperation.”
John Uiters, CEO with 25+ years of clinical trial experience in neuro-oncology.
Looking Ahead
The outcomes of the INTRAGO-II Trial, published in The Lancet Oncology, showed no additional clinical benefit from adding intraoperative radiotherapy to the current standard of care. While a negative clinical result, it provides important evidence for future neuro-oncological research and underscores the value of rigorous, well-controlled, multicentre randomised trials in answering clinical questions definitively. Whatever the answer turns out to be.
Like many oncology trials, INTRAGO-II used advanced imaging biomarker, here dynamic susceptibility contrast (DSC) perfusion imaging, next to the standardised RANO response evaluations. The increasing use of novel MRI and PET imaging markers adds further complexity and volume to the imaging data that clinical sites, CoreLabs/iCROs and study sponsors must coordinate throughout a trial.
We are proud to have supported the University Medical Centre Mannheim in this critical clinical endeavour, and look forward to applying the same standards of security, structure and traceability to multimodal imaging challenges ahead.