Cognition-preserving Brain Irradiation for Treating Patients With Intracranial Meningioma in the Era of Modern Radiotherapeutic Techniques Including Proton Beam Therapy - a Prospective Study Focusing on Radiological Outcomes and Neurocognitive Endpoints

NCT05832099 | Not Yet Recruiting

• 1 other identifier: 202202092A3
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

【Background】For cranial-irradiation-naive patients with intracranial meningiomas at risk of local recurrence, the administration of conformal cranial radiotherapy can enhance tumor control in the current era of modern radiotherapeutic techniques. Life expectancy in patients with intracranial meningiomas, particularly non-malignant meningiomas (WHO grade I and II) is essentially similar to people of general population. However, RT-related neurocognitive function (NCF) sequelae are potentially and seriously a concern which should not be ignored. In terms of the natural course of cranial irradiation-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline principally involves impairments of episodic memory, which is significantly associated with functions of the hippocampus. Additionally, the extent of changes in hippocampal volume after local irradiation may be associated with the hippocampal dosimetry. This study thus aims to investigate the potential cause-effect relationship between the hippocampal dosimetry and radiological outcomes represented by the volumetric changes regarding the contralateral hippocampus; furthermore, the correlation between radiological outcomes and neurocognitive endpoints will be examined and clarified. 【Methods】Patients with cranial-RT-naive intracranial meningiomas may be eligible and therefore enrolled in this prospective study addressing both radiological outcomes and neurocognitive endpoints. All eligible and recruited patients should receive baseline volumetric brain MRI examination and baseline neurobehavioral assessment. Subsequently, conformal cranial irradiation in the era of modern radiotherapeutic techniques (including hypofractionated stereotactic radiotherapy, proton beam therapy volumetric modulated arc therapy) will be utilized in order to reduce the dose irradiating the contralateral hippocampus and other relevant organs at risk. The prescribed dose schemes for treating patients with intracranial meningioma depend on the decision of the radiation oncologist in charge and follow the treatment guidelines at our cancer center. Accordingly, a battery of neurocognitive measures, which includes 9 standardized neuropsychological tests categorized into 5 NCF domains (e.g., executive functions, verbal \& non-verbal memory, working memory, psychomotor speed, and amygdala-related emotion recognition), is used to evaluate neurocognitive performances longitudinally for our registered patients. There will be two co-primary outcome measures in the current study. The main primary outcome will be the correlation between the mean hippocampal dose and the extent of change in hippocampal volume at 6 months after the course of cranial RT. The other primary endpoint will be 6-month cognitive-deterioration-free survival. 【Expected Results】This prospective observational cohort study aims to explore and investigate the cause-effect relationship between the hippocampal dosimetry (i.e., mean dose irradiating the hippocampus, particularly the one contralateral to the lateralization of intracranial meningioma) and the extent of hippocampal atrophy signifying one of the measures regarding radiological outcomes. Simultaneously, predefined standardized neurocognitive outcome measures such as hippocampus-related memory functions and amygdala-related emotion recognition will be obtained prospectively and longitudinally in order to examine whether any meaningfully significant correlation exists between the above radiological outcome measures and neurocognitive endpoints. The mutual associations among hippocampal dosimetry, radiological outcomes including the MRI-delineated hippocampal volume, and neurocognitive endpoints including hippocampus-related verbal/non-verbal memory functions will be examined thoroughly.

Conditions

Intracranial Meningioma

Keywords

Intracranial Meningioma; Radiation Therapy; Magnetic Resonance Image (MRI); Volumetric MRI; Functional MRI (fMRI); Radiological Outcomes; Hippocampus; Neurocognitive Functions (NCFs); Cognition-Preserving Brain Radiotherapy; Proton Beam Radiotherapy; Hippocampal Atrophy; Amygdala; Thalamus

Outcome Measures

Primary Outcomes (1)

• Longitudinal changes in the volumes of organs at risk including the hippocampus

  Longitudinal changes in the volumes (cc) of the left hippocampus, right hippocampus, left amygdala, right amygdala, left thalamus, right thalamus, and so on based on volumetric MR imaging examinations

  baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months

Secondary Outcomes (8)

• Change in verbal memory function

  baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months

• Change in non-verbal memory learning

  baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months

• Change in executive function

  baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months

• Change in emotion memory task

  baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months

• Change in working memory

  baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months

Study Arms (1)

Radiation

Conformal focal-brain irradiation using modern radiotherapeutic techniques (i.e., conventionally fractionated VMAT, hypofractionated stereotactic radiotherapy, and proton beam therapy, etc)

Radiation: Radiation

Interventions

Radiation RADIATION

The techniques of conformal focal-brain irradiation in the era of modern radiotherapy (i.e., conventionally fractionated VMAT, hypofractionated stereotactic radiotherapy, and proton beam therapy, etc)

Radiation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinically or pathologically-confirmed intracranial non-malignant meningiomas referred for arranging conformal focal-brain irradiation using modern radiotherapeutic techniques including volumetric modulated arc therapy (VMAT), hypofractionated stereotactic radiotherapy (SRT), and proton beam therapy.

You may qualify if:

• Patients with clinically or pathologically-confirmed intracranial non-malignant meningiomas who are at least 18 years old, referred for arranging conformal radiotherapy
• A Fair/good performance status superior to Eastern Cooperative Group (ECOG) of 2 or an acceptable performance status of Karnofsky Score (KPS) at least 70

You may not qualify if:

• History of prior radiotherapy delivered to brain/head region for any reason, including stereotactic radiosurgery
• Patients with malignant meningiomas diagnosed pathologically (WHO grade III)
• Patients with presumed clinical target volume (CTV) encompassing bilateral peri-hippocampal regions within 5 mm away from the adjacent periphery of the hippocampus
• Patients whose quality of volumetric MRI fails to meet the minimal requirements for physicians to delineate the hippocampal contouring (i.e., slice thickness \> 2mm)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Meningioma

Interventions

Radiation

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

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Chi-Cheng Chuang, M.D.

CONTACT

+88633281200; ccc2915@cgmh.org.tw

Shinn-Yn Lin, M.D.

CONTACT

+88633281200; rt3126@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 27, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 27, 2023

Record last verified: 2022-12

Locations

TW (1)