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

Meningioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638478
• Other study ID #: PRECODE-MRI
• Status: Recruiting
• Start date: April 8, 2021
• Est. completion date: April 8, 2025

Study information

• Verified date: November 2023
• Source: Maastricht Radiation Oncology
• Contact: Karen Zegers
• Phone: +31884455600
• Email: karen.zegers[@]maastro.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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%. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: April 8, 2025
• Est. primary completion date: April 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Meningioma

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht Radiation Oncology	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Maastricht University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	2 years after radiotherapy
Secondary	RT induced cognitive change measured with extensive cognitive testing	RT-induced cognitive change measured with extensive cognitive testing	2 years after radiotherapy
Secondary	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)	2 years after radiotherapy
Secondary	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.	2 years after radiotherapy
Secondary	Sensitivity neurocognitive tests	Sensitivity of additional extensive neurocognitive tests	2 years after radiotherapy
Secondary	Correlation advanced MRI and radiotherapy modality	Correlation of advanced MRI and treatment/dose parameters and radiotherapy modality (photon vs proton)	2 years after radiotherapy