Cerebral radiation necrosis
Conditions
Interventions
Group 1: This is a retrospective, single-center observational study without intervention. Patients with cerebral radionecrosis following radiotherapy for brain tumors who were treated with bevacizumab
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with diagnosed cerebral radiation necrosis following prior radiotherapy for a brain tumor (e.g., glioblastoma, astrocytoma, oligodendroglioma, or brain metastases) Treatment with bevacizumab between January 1, 2022 and January 1, 2026 Availability of at least one magnetic resonance imaging (MRI) scan prior to initiation of bevacizumab therapy (baseline) and at least one MRI scan after completion of therapy Availability of relevant imaging data of sufficient quality for analysis Availability of essential clinical baseline data (e.g., age, sex, clinical course)
Exclusion criteria
Exclusion criteria: Missing or incomplete longitudinal imaging data (no comparability between pre- and post-therapeutic scans) Insufficient image quality precluding volumetric analysis Missing key clinical follow-up data Patients with predominant suspicion of tumor progression rather than radiation necrosis Duplicate inclusion of the same patient (in such cases, only one dataset will be included)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint (target outcome): Volumetric change of contrast-enhancing lesions (T1 + contrast agent) on MRI under bevacizumab therapy. Time point of assessment: Comparison between baseline MRI before initiation of bevacizumab therapy and MRI after completion of therapy. Optional follow-up examinations are included if available. Data collection: Data are collected retrospectively based on existing clinical documentation and radiological imaging (MRI) from the institution’s internal PACS system. Volumetric analysis is performed using specialized software (Brainlab SmartBrush). Clinical parameters are extracted from electronic patient records and analyzed in a pseudonymized manner. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Volumetric change of T2/FLAIR hyperintensity on MRI as a surrogate parameter for perilesional edema or radionecrosis. Correlation between radiological volume changes (T1 + contrast agent and T2/FLAIR) and clinical response (e.g., symptoms, Karnofsky Performance Status). Changes in clinical parameters over time, particularly neurological symptoms, Karnofsky Performance Status, and steroid requirement. Exploratory subgroup analyses of treatment response depending on tumor entity and prior therapies. | — |
Countries
Germany
Contacts
Public ContactDavid Wasilewski
Universitätsklinikum Düsseldorf
Outcome results
None listed