About this trial
Meningioma are slow growing and frequently occurring intracranial tumors, responsible for 33% of all asymptomatic intracranial tumors and 13-26% of all symptomatic primary brain tumors. The 10-year survival rate is 72%. A variety of treatment options is available for symptomatic meningioma including surgical removal with or without radiotherapy or radiotherapy alone. These therapies can have negative impact on cerebral functioning.
After high dose radiotherapy for primary or metastatic brain tumors 50-90% of \> 6 months' survivors develop irreversible disabling cognitive decline leading to premature loss of independence, reduced Quality of Life (QOL) as well as significant economic burden both at the individual as societal level. Especially for patients with a good prognosis like benign meningioma, maintaining neurocognitive function is crucial. Understanding the mechanisms underlying radiation induced cognitive decline is complex and which brain areas to spare are an important subject of research.
Evaluation methods to assess cognitive function and predict cognitive decline are urgently needed, this will allow the development of optimized treatment strategies with the aim to preserve or even improve cognitive function in meningioma patients. Improvements in the field of neuroimaging techniques (i.e. advanced MRI techniques) have the possibility to identify areas susceptible to cognitive impairment. This allows in the future a more personalized radiation treatment by identifying patients at risk, by optimizing the radiotherapy dose to specific brain regions, that could eventually reduce or prevent, cognitive decline. Improvements in the field of radiotherapy for example by higher precision treatment such proton therapy have potential in obtaining these more individualized strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meningioma WHO I, grading based on pathology or radiological features
Age ≥ 18 years.
Karnofsky Performance Score 70 or above.
Ability to comply with the protocol, including neuropsychological testing and imaging.
Disqualifiers
Resection meningioma < 3mnd
Age < 18 years
Pregnancy
Any prior cranial radiotherapy
Trial population
Adult (18 years or older) patients with meningioma tumours (WHO I) in a good clinical condition treated with curative intend using radiotherapy (proton or photon) without other known malignancies.
Trial design
Cohort
Prospective
Treatments tested in this trial
PRECODE-MRI
Other interventionPatients with meningioma WHO I tumours treated with radiotherapy will be included, undergoing extensive cognitive testing combined with advanced brain MRI scans just before, 3 and 24 months after radiotherapy
Treatment groups
Trial outcomes
Primary outcomes
Correlation cognitive failure and radiotherapy dose
Correlation between the delta cognitive failure score (baseline vs 2 years) and radiotherapy dose in cognition related brain regions (supratentorial brain, hippocampus left/right and anterior/posterior, cerebellum anterior/posterior).
Secondary outcomes
Correlation baseline imaging and patient specific parameters
Correlation between baseline imaging (advanced MRI sequence) and patient specific parameters (e.g. baseline cognitive status, age, Karnofsky index (KPS), co-morbidity, alcohol consumption, smoking, medication)
RT induced cognitive change measured with extensive cognitive testing
RT-induced cognitive change measured with extensive cognitive testing
Correlation advanced MRI and PROMS
Correlation of advanced MRI and treatment/dose parameters to PROMS; EQ/5D, QLQ/C30, QLQ/BN20, Cognitive Failure questionnaire (CFQ) , Multidimentional Fatigue Index (MVI/20)
Radiation susceptibility of organs by Normal Tissue Complication Probability (NTCP)
Identification of radiation susceptibility of individual anatomical and functional central nervous system (CNS) organs (e.g. (hippocampi, frontal lobe, cerebellum, brain) for radiation damage by relating dose-volume histogram of the organs with information with neurocognitive test results.
Sponsors and contacts
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Maastricht Radiation Oncology
Lead sponsor
Maastricht University Medical Center
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator