The goal of this multicenter prospective longitudinal study is to study the long-term impact of multimodal treatment (chemotherapy, radiotherapy and surgery) in adult brain and base of skull tumors on neurocognitive functioning. All included patients will complete a self-report inventory (subjective cognitive functioning, QoL, confounders), a cognitive test battery, an advanced MR at multiple timepoints. Moreover, toxicity will be scored according to the CTCAEv5.0 in these patients over time.
This study will combine MR imaging techniques together with elaborate neuropsychological assessments and RT dosimetry in 120 patients who will be examined baseline (before RT) and followed longitudinally after RT. The first objective is to build an NTCP model for neurocognitive decline after RT (for each cognitive domain separately), linking dose-volume parameters to structures within the brain susceptible to neurological damage and neurocognitive decline after radiotherapy. These NTCP models can be used to make predictions on neurocognitive decline in future primary brain tumour patients receiving cranial RT. The second objective is to evaluate dose-dependent neurocognitive decline. In particular, the investigators will assess: * Prevalence and severity of neurocognitive decline after RT for all cognitive domains * Brain structures or functional brain connections important in neurocognitive functioning (based on dedicated MRI). * Dose-dependencies of specific neurocognitive skills after RT in adult brain tumour patients * Correlations between RT dosimetry and early brain changes (MRI)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Primary brain tumour patients will be evaluated longitudinally at the following timepoints: baseline (minimal 4 weeks after surgery, before radiotherapy), three months after end of radiotherapy, 1 year after end of radiotherapy and 2 years after end of radiotherapy. At each visit, neurocognitive testing, a self-report inventory and/or advanced MR imaging will take place. Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy
Advanced MRI: all participants will be scanned on a 3T Siemens of Philips MR scanner (multicenter protocol): MPRAGE, FLAIR, T2, DWI, rsfMRI, SWI \& ASL Time points: baseline, 3 months post-radiotherapy and 12 months post-radiotherapy
Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy
During and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0.
University Hospitals Ghent
Ghent, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGGasthuis Zusters Antwerpen
Wilrijk, Belgium
RECRUITINGPrevalence of neurocognitive decline (changes in z-scores) compared to baseline at one year post-radiotherapy, for all cognitive domains (memory, executive functioning, attention and language)
Time frame: 2 years
Development of a Normal Tissue Complication Probability model (NTCP-model) for each cognitive domain (memory, executive functioning, attention and language)
Construct NTCP models to predict neurocognitive decline based on RT dosimetric and other explanatory variables (gender, age at diagnosis, comorbidities, level of education, social factors such as social activity and occupation, tumour size and localization, pathological/genetic/molecular characteristics, therapy protocols (surgery, radiotherapy and/or chemotherapy)) in an NTCP model for each cognitive domain
Time frame: 4 years
Early (3 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures)
Changes on advanced MR imaging at 3 months post-RT compared to baseline
Time frame: 4 years
Late (12 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures)
Changes on advanced MR imaging at 12 months post-RT compared to baseline
Time frame: 4 years
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