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Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
Sponsor: Universitaire Ziekenhuizen KU Leuven
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.
Official title: Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-02-08
Completion Date
2027-02-01
Last Updated
2024-05-08
Healthy Volunteers
No
Interventions
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
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
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
Toxicity scoring
During and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0.
Locations (3)
University Hospitals Ghent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Gasthuis Zusters Antwerpen
Wilrijk, Belgium