Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617208
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Prognostic IntraOperative Biomarkers IdeNtification in Tumor RElatEd SuRgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prognostic IntraOperative Biomarkers IdeNtification in Tumor RElatEd SuRgery PIONEER Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIONEER
Brief Summary:
INTRODUCTION AND RATIONALE
Aggressive brain tumors like glioma have the ability to infiltrate the surrounding healthy brain tissue disrupting normal neuronal activities and leading to impaired motor and cognitive functions as well as causing epilepsy This malignant brain tumor is considered one of the most challenging cancers to treat with a median survival of 12 to 15 months Recent findings on direct neuron-tumor interactions indicate that abnormal brain activity in the regions surrounding brain tumors may contribute to develop epilepsy and accelerating tumor growth Tumors tend to fuel themselves with neurotransmitters released during its daily neuronal firing Hyperactive neurons in the peritumoral cortex can form excitatory electrochemical synapses with surrounding tumor cells creating direct communication pathways within the peritumoral microenvironment which aids in the progression and proliferation of tumor cells via direct and paracrine signalling pathways However the specific features of this abnormal brain activity in the peritumoral cortex have not been fully clarified and information on the pathological changes of neuronal activity in glioma patients is largely lacking To advance more effective treatment strategies it is crucial to better understand the complex interactions between the tumor and the brain
This is especially important for the group of patients of which many perceive diminished quality of life because of epilepsy cognitive functioning and language problems after tumor surgery Furthermore a thorough understanding is lacking of what tumor resection does to the original hyperactive peritumoral cortex and if resecting this is beneficial for improving postoperative outcome both for epilepsy as well as regarding survival Therefore identifying the hyperactive peritumoral cortex and directly addressing its impacts on the brain function and long-term surgical outcome could be a promising novel therapeutic strategy for treating glioma patients
STUDY AIM
The measurement focuses on capturing neuronal activity at single-neuron resolution in the peritumoral cortex of glioma patients using cortical depth electrodes It is well-established that gliomas can remodel the surrounding brain tissue leading to abnormal neuronal hyperactivity which contributes to tumor progression and epilepsy However the specific neuronal patterns and underlying mechanisms of these changes are not yet fully understood This study will aim to collect detailed single-neuron recordings in this context enabling us to map the precise neurophysiological disruptions caused by gliomas On the long term this research could lay the groundwork in identifying novel therapeutic approaches by providing critical in-sights into how gliomas alter brain function
Aggressive brain tumors like glioma have the ability to infiltrate the surrounding healthy brain tissue disrupting normal neuronal activities and leading to impaired motor and cognitive functions as well as causing epilepsy This malignant brain tumor is considered one of the most challenging cancers to treat with a median survival of 12 to 15 months Recent findings on direct neuron-tumor interactions indicate that abnormal brain activity in the regions surrounding brain tumors may contribute to develop epilepsy and accelerating tumor growth Tumors tend to fuel themselves with neurotransmitters released during its daily neuronal firing Hyperactive neurons in the peritumoral cortex can form excitatory electrochemical synapses with surrounding tumor cells creating direct communication pathways within the peritumoral microenvironment which aids in the progression and proliferation of tumor cells via direct and paracrine signalling pathways However the specific features of this abnormal brain activity in the peritumoral cortex have not been fully clarified and information on the pathological changes of neuronal activity in glioma patients is largely lacking To advance more effective treatment strategies it is crucial to better understand the complex interactions between the tumor and the brain
This is especially important for the group of patients of which many perceive diminished quality of life because of epilepsy cognitive functioning and language problems after tumor surgery Furthermore a thorough understanding is lacking of what tumor resection does to the original hyperactive peritumoral cortex and if resecting this is beneficial for improving postoperative outcome both for epilepsy as well as regarding survival Therefore identifying the hyperactive peritumoral cortex and directly addressing its impacts on the brain function and long-term surgical outcome could be a promising novel therapeutic strategy for treating glioma patients
STUDY AIM
The measurement focuses on capturing neuronal activity at single-neuron resolution in the peritumoral cortex of glioma patients using cortical depth electrodes It is well-established that gliomas can remodel the surrounding brain tissue leading to abnormal neuronal hyperactivity which contributes to tumor progression and epilepsy However the specific neuronal patterns and underlying mechanisms of these changes are not yet fully understood This study will aim to collect detailed single-neuron recordings in this context enabling us to map the precise neurophysiological disruptions caused by gliomas On the long term this research could lay the groundwork in identifying novel therapeutic approaches by providing critical in-sights into how gliomas alter brain function
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None