Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04638478

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht Radiation Oncology

Maastricht, Limburg, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 in the last 5 years
  • 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)

Treatment and study plan

PRECODE-MRI

Other

Patients 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

Primary outcomes

  1. Correlation cognitive failure and radiotherapy dose

    Time frame: 2 years after radiotherapy

    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

  1. Correlation baseline imaging and patient specific parameters

    Time frame: 2 years after radiotherapy

    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)

  2. RT induced cognitive change measured with extensive cognitive testing

    Time frame: 2 years after radiotherapy

    RT-induced cognitive change measured with extensive cognitive testing

  3. Correlation advanced MRI and PROMS

    Time frame: 2 years after radiotherapy

    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)

  4. Radiation susceptibility of organs by Normal Tissue Complication Probability (NTCP)

    Time frame: 2 years after radiotherapy

    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.

  5. Sensitivity neurocognitive tests

    Time frame: 2 years after radiotherapy

    Sensitivity of additional extensive neurocognitive tests

  6. Correlation advanced MRI and radiotherapy modality

    Time frame: 2 years after radiotherapy

    Correlation of advanced MRI and treatment/dose parameters and radiotherapy modality (photon vs proton)

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Maastricht University Medical Center
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Nov 20, 2020
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.