NCT05727605

Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Cognition
• Brain Tumor
• Magnetic Resonance Imaging
• Meningioma
• Glioma
• Pituitary Adenoma

Interventions

Type	Name	Description
BEHAVIORAL	Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test	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
DIAGNOSTIC_TEST	MRI	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
BEHAVIORAL	Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI	Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy
OTHER	Toxicity scoring	During and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0.

Timeline

• Start date: 2023-02-08
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2023-02-14
• Last updated: 2024-05-08

Locations

3 sites across 1 country: Belgium