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

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ClinicalTrials.gov Identifier: NCT04638478
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : January 4, 2023
Sponsor:
Collaborators:
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Study Description
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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.


Condition or disease Intervention/treatment
Meningioma Other: PRECODE-MRI

Study Design
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Study Type : Observational
Estimated Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PREselection of Patients at Risk for COgnitive DEcline After Radiotherapy Using Advanced MRI
Actual Study Start Date : April 8, 2021
Estimated Primary Completion Date : April 8, 2025
Estimated Study Completion Date : April 8, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638478


Contacts
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Contact: Karen Zegers +31884455600 karen.zegers@maastro.nl
Contact: Danielle Eekers +31884455600 danielle.eekers@maastro.nl

Locations
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Netherlands
Maastricht Radiation Oncology Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Karen Zegers    +31884455600    karen.zegers@maastro.nl   
Contact: Danielle Eekers    +31884455600    danielle.eekers@maastro.nl   
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Study Chair: Karen Zegers Maastro Clinic, The Netherlands
Principal Investigator: Danielle Eekers Maastro Clinic, The Netherlands
More Information
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT04638478    
Other Study ID Numbers: PRECODE-MRI
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: January 4, 2023
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht Radiation Oncology:
Meningioma
Radiotherapy
MRI
Neurocognition
Additional relevant MeSH terms:
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Meningioma
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
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