Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult patients (≥ 18 years at the time of diagnosis) with a primary brain or base of skull tumour, who are amenable for conventionally fractionated radiotherapy (photon or proton irradiation)
Exclusion Criteria:
- Patients with tumours with poor prognostic characteristics: - Incompletely resected IDH-wild-type glioma.

- Completely resected IDH-wild-type and MGMT-promotor unmethylated glioma.

- grade III meningioma.

- H3K27M+ midline glioma.

- Patients with tumours requiring craniospinal irradiation (CSI)/whole ventricular irradiation (WVI) - Hypofractionated/stereotactic radiation (fraction sizes > 2 Gy per fraction) - Inability to perform the cognitive tests or self-report inventories because of motor/sensory deficits or insufficient Dutch language proficiency.

- Mental retardation documented before diagnosis.

- Pre-diagnosis/pre-existing psychiatric diagnosis resulting in cognitive deficits like psychoses, neurodevelopmental disorders (autism/learning disorders) - Relapse previously treated by chemo and/or radiation therapy.

- Genetic syndrome (e.g. Down) - Unable to perform MR imaging (claustrophobia, metallic implants like pacemaker/ICD/neurostimulator)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05727605
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universitaire Ziekenhuizen KU Leuven
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Maarten Lambrecht, MD PhD
Principal Investigator Affiliation	UZ Leuven
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cognition, Brain Tumor, Magnetic Resonance Imaging, Meningioma, Glioma, Pituitary Adenoma

Additional Details

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)

Arms & Interventions

Arms

Other: Primary brain and skull-base tumors

Primary brain and skull-base tumors who are amenable for radiotherapy (photon or proton therapy) will all be examined with neurocognitive tests, questionnaires and advanced MR imaging

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.

Contact a Trial Team

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