Actively Recruiting
Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-05-08
120
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
U
University Hospital, Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the long-term effects of multimodal treatment including chemotherapy, radiotherapy, and surgery on neurocognitive function in adults with primary brain and base of skull tumors. This study focuses on understanding how radiotherapy impacts cognitive skills such as memory, executive functioning, attention, and language, by linking radiation dose to brain areas vulnerable to damage. The goal is to develop predictive models for neurocognitive decline to aid future treatment planning. Participants will undergo detailed neurocognitive testing, complete self-report questionnaires on cognitive function and quality of life, and receive advanced MRI scans at multiple timepoints. Treatments include photon or proton radiotherapy. Assessments occur before radiotherapy, and then at 3 months, 12 months, and 24 months after radiotherapy. Toxicity and adverse effects will be monitored throughout the study using standardized scoring. During the study, patients will complete cognitive tests such as WAIS digit span, HVLT-R, and Stroop Color Word Test, alongside questionnaires like EORTC QLQ C30 & BN20, STAI, and BDI-II. MRI scans will assess structural and functional brain changes at baseline, 3 months, and 12 months post-radiotherapy. Researchers will measure changes in cognitive scores compared to baseline to evaluate neurocognitive decline and develop prediction models. Safety monitoring will continue until study completion, with total follow-up lasting up to 2 years after radiotherapy.
CONDITIONS
Brief Title
Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older at diagnosis
- Diagnosed with a primary brain or base of skull tumor
- Suitable for conventionally fractionated radiotherapy (photon or proton therapy)
You will not qualify if you...
- Tumors with poor prognostic features such as incompletely resected IDH-wild-type glioma
- Completely resected IDH-wild-type and MGMT-promotor unmethylated glioma
- Grade III meningioma
- H3K27M positive midline glioma
- Tumors requiring craniospinal or whole ventricular irradiation
- Hypofractionated or stereotactic radiation with fraction sizes greater than 2 Gy
- Inability to complete cognitive tests or questionnaires due to motor/sensory deficits or insufficient Dutch language
- Documented mental retardation before diagnosis
- Pre-existing psychiatric diagnoses causing cognitive deficits
- Previous relapse treated by chemotherapy or radiation
- Genetic syndromes such as Down syndrome
- Inability to undergo MRI due to claustrophobia or implanted devices like pacemaker, ICD, or neurostimulator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline period before radiotherapy
Participants undergo advanced MR imaging and neurocognitive testing before radiotherapy to assess baseline brain function and structure.
1 baseline visit (in-person)
Duration - Duration of radiotherapy treatment
Participants receive conventionally fractionated radiotherapy (photon or proton therapy). Toxicity and adverse events are monitored during and after radiotherapy.
Visits during and at end of radiotherapy for toxicity scoring
Duration - Up to 2 years post-radiotherapy
Participants are followed longitudinally with neurocognitive assessments, questionnaires, and advanced MR imaging to monitor neurocognitive decline and brain changes after radiotherapy.
Visits at 3 months, 12 months, and 24 months post-radiotherapy
Trial Site Locations
Total: 3 locations
1
University Hospitals Ghent
Ghent, Belgium
Actively Recruiting
2
UZ Leuven
Leuven, Belgium
Actively Recruiting
3
Gasthuis Zusters Antwerpen
Wilrijk, Belgium
Actively Recruiting
Research Team
L
Laurien De Roeck, MD
M
Maarten Lambrecht, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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