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

NCT04638478 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

  • Meningioma

Interventions

OTHER

PRECODE-MRI

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

Sponsors & Collaborators

  • Maastricht University Medical Center

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht Radiation Oncology

    lead OTHER

Principal Investigators

  • Karen Zegers · Maastro Clinic, The Netherlands

  • Danielle Eekers · Maastro Clinic, The Netherlands

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2026-05-01
Completion
2029-05-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638478 on ClinicalTrials.gov