Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• University Hospital, Ghent

  collaborator OTHER

• Gasthuis Zusters Antwerpen

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Maarten Lambrecht, MD PhD · UZ Leuven

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-08

Primary Completion

2026-02-01

Completion

2027-02-01

Countries

• Belgium

Study Locations