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

NCT04638478 | Recruiting

• 1 other identifier: PRECODE-MRI
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Meningioma; Radiotherapy; MRI; Neurocognition

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years after radiotherapy

Secondary Outcomes (6)

• Correlation baseline imaging and patient specific parameters

  2 years after radiotherapy

• RT induced cognitive change measured with extensive cognitive testing

  2 years after radiotherapy

• Correlation advanced MRI and PROMS

  2 years after radiotherapy

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

  2 years after radiotherapy

• Sensitivity neurocognitive tests

  2 years after radiotherapy

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastricht University Medical Center: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, Limburg, 6202 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• Karen Zegers

  Maastro Clinic, The Netherlands

  STUDY CHAIR

• Danielle Eekers

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Zegers

CONTACT

+31884455600; karen.zegers@maastro.nl

Danielle Eekers

CONTACT

+31884455600; danielle.eekers@maastro.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 20, 2020
• Study Start: April 8, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)