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| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
| Gasthuis Zusters Antwerpen | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary brain and skull-base tumors | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of neurocognitive decline (changes in z-scores) compared to baseline at one year post-radiotherapy, for all cognitive domains (memory, executive functioning, attention and language) | 2 years | |
| Development of a Normal Tissue Complication Probability model (NTCP-model) for each cognitive domain (memory, executive functioning, attention and language) | Construct NTCP models to predict neurocognitive decline based on RT dosimetric and other explanatory variables (gender, age at diagnosis, comorbidities, level of education, social factors such as social activity and occupation, tumour size and localization, pathological/genetic/molecular characteristics, therapy protocols (surgery, radiotherapy and/or chemotherapy)) in an NTCP model for each cognitive domain | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Early (3 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures) | Changes on advanced MR imaging at 3 months post-RT compared to baseline | 4 years |
| Late (12 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with tumours with poor prognostic characteristics:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurien De Roeck, MD | Contact | 016 34 76 00 | Laurien.deroeck@uzleuven.be | |
| Maarten Lambrecht, MD PhD | Contact | 016 34 76 00 | Maarten.lambrecht@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Maarten Lambrecht, MD PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Ghent | Recruiting | Ghent | Belgium |
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|
| MRI | Diagnostic Test | 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 | Behavioral | Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy |
|
| Toxicity scoring | Other | During and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0. |
|
Changes on advanced MR imaging at 12 months post-RT compared to baseline |
| 4 years |
| UZ Leuven | Recruiting | Leuven | Belgium |
|
| Gasthuis Zusters Antwerpen | Recruiting | Wilrijk | Belgium |
|
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D008579 | Meningioma |
| D005910 | Glioma |
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D004701 | Endocrine Gland Neoplasms |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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