AzTrials
AzTrials

MeningiomaNCT04638478

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

An observational study of Meningioma, run by Maastricht Radiation Oncology at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningioma
What is being tested?
PRECODE-MRI
How many people
67 participants
Where
1 siteNetherlands
Study dates
8 Apr 2021to 1 May 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht Radiation Oncology

    Maastricht, Limburg, 6202 AZ

Other trials in Netherlands

About this study

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
Being tested
PRECODE-MRI
Keywords
Meningioma, Radiotherapy, MRI, Neurocognition
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRECODE-MRIOther

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 2 years after radiotherapy

Secondary outcomes (6)

  1. 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)

    Measured: 2 years after radiotherapy

  2. RT induced cognitive change measured with extensive cognitive testing

    RT-induced cognitive change measured with extensive cognitive testing

    Measured: 2 years after radiotherapy

  3. 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)

    Measured: 2 years after radiotherapy

  4. 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.

    Measured: 2 years after radiotherapy

  5. Sensitivity neurocognitive tests

    Sensitivity of additional extensive neurocognitive tests

    Measured: 2 years after radiotherapy

  6. Correlation advanced MRI and radiotherapy modality

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

    Measured: 2 years after radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start8 Apr 2021
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion1 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04638478
Sponsor's protocol ID
PRECODE-MRI
Status last verified
Jun 2026
First submitted
5 Nov 2020
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Meningioma, run by Maastricht Radiation Oncology at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation cognitive failure and radiotherapy dose (time frame: 2 years after radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04638478.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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