An observational study in Intracranial Meningioma, sponsored by Chang Gung Memorial Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Chang Gung Memorial Hospital · Observational
【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.
226 studies on the registry are indexed under Meningioma; 87 are open to participants now.
This study's planned enrollment of 74 is below the median of 132 across 56 observational studies indexed under Meningioma.
Browse Meningioma studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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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.
Exclusion Criteria:
Conformal focal-brain irradiation using modern radiotherapeutic techniques (i.e., conventionally fractionated VMAT, hypofractionated stereotactic radiotherapy, and proton beam therapy, etc)
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)
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
Time frame: baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months
Change in verbal memory function
Change in verbal memory function related to left hippocampus from baseline to 4 months after cognition-preserving cranial RT
Time frame: baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months
Change in non-verbal memory learning
Change in non-verbal memory learning associated with right hippocampus from baseline to 4 months after cognition-preserving brain RT
Time frame: baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months
Change in executive function
Change in executive function related to hippocampus from baseline to 4 months after cognition-preserving cranial RT. Concerning the domain of executive functions generally dominated by the frontal lobes, the Modified Card Sorting Test is employed to assess both conceptual formation and mental shifting which have been documented to be the major components of executive functions.
Time frame: baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months
Change in emotion memory task
Change in emotion memory tasks associated with the amygdala from baseline to 4 months after cognition-reserving cranial irradiation. For evaluate and quantify the cognitive function of amygdala, the NCF test tailored to the emotional recognition task will be used and patients' performances will be assessed using the commercialized and computerized test included in Cambridge Cognition® package.
Time frame: baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months
Change in working memory
Change in working memory related to hippocampus from baseline to 4 months after cognition-preserving cranial RT. Working memory includes executive functions and psychomotor speed. * The neurocognitive outcome of verbal working memory was determined by the Digit Span Subtest (DS) and Spatial Span (SSP) of the Wechsler Adult Intelligence Scale- 3rd edition (WAIS-III®). * In order to indicate patients' performance on the psychomotor speed, we make use of Psychomotor Speed Index (PSI), which is derived from the composite score of Digit Symbol Coding Subtest (DSS) and Symbol Searching Subtest (SS) of the WAIS-III®.
Time frame: baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months
Longitudinal changes in the imaging biomarkers
Longitudinal changes in the imaging biomarkers from DTI imaging
Time frame: baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months
Longitudinal changes in the fractional anisotropy
Longitudinal changes in the fractional anisotropy (FA, unitless index between 0 and 1) from DTI imaging
Time frame: baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months
Trajectories in the imaging biomarker
Trajectories in the imaging biomarker, mean diffusivity (MD, mm squared/second) based on DTI imaging
Time frame: baseline (pre-RT), 4 months, 8-10 months (optional), 12 months, 18 months, 24 months
This study is not yet recruiting, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital