PREselection of Patients at Risk for COgnitive DEcline After Radiotherapy Using Advanced MRI

  • STATUS
    Recruiting
  • End date
    Apr 8, 2025
  • participants needed
    67
  • sponsor
    Maastricht Radiation Oncology
Updated on 20 April 2022
proton therapy

Summary

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.

Details
Condition Meningioma
Treatment PRECODE-MRI
Clinical Study IdentifierNCT04638478
SponsorMaastricht Radiation Oncology
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician
Written informed consent

Exclusion Criteria

Resection meningioma < 3mnd
Age < 18 years
Pregnancy
Any prior cranial radiotherapy
Any prior chemotherapy
Contra-indication for MR imaging (i.e. metal implants, claustrophobia)
Any other serious medical condition that could interfere with follow-up
Severe aphasia or language barrier interfering with assessing endpoints (i.e. completion of questionnaires or neurocognitive performance)
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