Imaging Infrastructure for Early-Phase Oncology Research
The GLORIA phase I/II trial used multiparametric MRI to investigate treatment effects in glioblastoma. The protocol included diffusion-derived ADC and perfusion-derived measures such as rCBV and FTBhigh. These biomarkers helped assess changes in tumour vascularisation. The imaging CRO MedWave coordinated the central imaging review using ClinFlows’ web-based decidemedical platform. The workflow connected six German academic centres, the sponsor and the central reader in a single, traceable environment.
Client
A biotechnological company developing novel aptamer-based therapies targeting the tumour microenvironment, in collaboration with six academic neuro-oncology centres in Germany and imaging CRO MedWave in the Netherlands.
Project
The GLORIA phase I/II trial investigated radiotherapy in combination with olaptesed pegol (NOX-A12). NOX-A12 is an L-RNA aptamer targeting CXCL12. The trial enrolled patients with newly diagnosed, MGMT-unmethylated glioblastoma (GBM). It later expanded to explore dual inhibition of tumour vascularisation by adding bevacizumab, an antibody targeting the VEGF pathway.
Why imaging was so important
The researchers wanted to go beyond tumour volumetry and conventional response assessment. Their scientific question was more complex: How does this therapy affect tumour vascularisation within the tumour microenvironment (TME)?
To address this, the imaging protocol incorporated multiparametric MRI, including diffusion-weighted (ADC) and perfusion-weighted measures (rCBV, FTBhigh). Further details are available in the published trial reports: Giordano, Layer, Leonardelli et al., 2024 (dose-escalation arm) and Giordano et al., 2026 (expansion arm). A blinded, independent reader centrally assessed the brain images to ensure objective and standardised evaluations. Central review was done using modified RANO (mRANO) criteria
Challenge
In early-phase oncological research, like GLORIA, every patient and every image is scientifically valuable. The novel aptamer-based therapy offered a promising approach for this particularly aggressive and treatment-resistant form of GBM. It also provided an opportunity to gain a better understanding of the TME’s functions. Before this potential could be explored, three major hurdles had to be overcome:
1. Specialist expertise
Requirements for this biomarker-rich project extended beyond image transfer and centralised review. Deep neuro-oncological expertise was needed to define reliable imaging endpoints, develop the imaging charter and establish the imaging analysis methodology.
2. Imaging complexity
Combining standard tumour response assessment with multiparametric MRI imaging required a complex imaging workflow across multiple timepoints and treatment cohorts.
3. A connected workflow
MRI images had to move quickly and efficiently from sites to expert readers. Time was critical as central review was relevant for safety monitoring and for treatment discussions in interdisciplinary tumour boards. Case-related information and reports also needed to remain accessible to the sponsor and imaging CRO. For an emerging biotechnology company, building this combination of specialist expertise and digital infrastructure in-house would have required significant operational resources.
Solution
GLORIA’s imaging needs were driven by scientific exploration – unlike later-stage trials, where imaging is largely about confirming efficacy and moving scans consistently from A to B. The workflow therefore needed to be structured, but flexible enough to evolve with the research.
Here’s how the imaging workflow worked:
MedWave brought the specialist imaging expertise and contributed to the study’s imaging endpoints. Tailored to GLORIA’s research hypotheses, they developed an imaging charter that accounted for advanced MRI image acquisition and central analysis.
ClinFlows provided the digital infrastructure through decidemedical, handling the logistics for DICOM exchange and study-specific pseudonymization of patient data. Participating sites uploaded MRI examinations through a secure web interface and entered study-specific clinical information relevant to image analysis. The platform automatically notified the imaging team when new MRI scans became available. Its DICOM preview function allowed Medwave to instantly check image completeness and quality before central assessment. When images or sequences required clarification, Medwave and participating sites could communicate through integrated query and discussion tools. The communication remained linked to the relevant case, eliminating fragmented email correspondence. Following quality control, the independent, central reader performed the MRI review using advanced neuroimaging software, including IB NeuroTM.
The cooperation between MedWave and ClinFlows allowed the sponsor to access specialist imaging capabilities without building and maintaining its own image-exchange infrastructure.
Result
The result was a customised, structured imaging workflow that combined scientific expertise with technical and operational resources, without requiring the sponsor to build or maintain its own image exchange platform.
Six neuro-oncology centres (Mannheim, Bonn, Leipzig, Essen, Tübingen, Münster) exchanged MRI examinations with MedWave’s imaging experts through decidemedical. In total, 189 MRI examinations (50 baseline, 139 follow-up scans) were transferred securely and efficiently via decidemedical.
The platform provided one traceable environment for image exchange, quality control, case-related communication and reporting.
“Evaluating drugs with antivascular properties only made sense with advanced imaging, including diffusion and perfusion sequences. Central, independent, and rapid MRI review at consistently high quality was thus essential to our multicentric trial. It meaningfully improved treatment decisions and gave us a level of quality assurance that local reads alone could not have provided.”
Head of Translational Oncology and Principal Investigator, GLORIA Trial
Looking Ahead
The GLORIA trial illustrates how a structured imaging workflow can support the scientific complexity of an early-phase oncology programme, even as protocols evolve. The same platform was used in INTRAGO-II, a phase III trial with 18 sites and 298 patients across seven countries. Together, the two studies demonstrate how the same infrastructure can support different stages of clinical development.
As quantitative MRI, PET and other advanced imaging techniques become increasingly important in oncological research, strong scientific, technical and operational expertise will further grow.
A well-thought-out imaging workflow established early in development can provide a foundation for reliable, standardised imaging endpoints in later-stage trials.
Planning an early-phase clinical trial in neuro-oncology?
Get in touch with our colleagues at MedWave and us. Together, we can help you build an imaging workflow suited to your study.
You focus on the scientific questions: understanding treatment effects, identifying meaningful imaging biomarkers and generating evidence to guide the next stage of clinical development. We take care of the imaging infrastructure and workflow to support you.
