RecruitingNot ApplicableNCT05727605

Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

120 participants

Start Date

Feb 8, 2023

Study Type

INTERVENTIONAL

Conditions

Brain Tumor Meningioma Magnetic Resonance Imaging Glioma Cognition Pituitary Adenoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how radiation therapy to the brain or skull base affects thinking, memory, and cognition over time. By tracking patients before and after radiotherapy, researchers hope to understand cognitive side effects and find ways to minimize them. **You may be eligible if...** - You are 18 or older - You have a primary brain tumor or a tumor at the base of the skull - You are scheduled to receive standard fractionated radiotherapy (photon or proton) **You may NOT be eligible if...** - Your tumor is a high-grade glioblastoma (IDH-wild-type) with incomplete removal - Your prognosis is very poor based on tumor type and treatment response - You cannot complete cognitive assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNeurocognitive 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_TESTMRI

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

BEHAVIORALQuestionnaires: 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

OTHERToxicity 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

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NCT05727605

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