Nctid:
NCT06617208
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000005909", "term"=>"Glioblastoma"}, {"id"=>"D000005910", "term"=>"Glioma"}], "ancestors"=>[{"id"=>"D000001254", "term"=>"Astrocytoma"}, {"id"=>"D000018302", "term"=>"Neoplasms, Neuroepithelial"}, {"id"=>"D000017599", "term"=>"Neuroectodermal Tumors"}, {"id"=>"D000009373", "term"=>"Neoplasms, Germ Cell and Embryonal"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009380", "term"=>"Neoplasms, Nerve Tissue"}], "browseLeaves"=>[{"id"=>"M9019", "name"=>"Glioblastoma", "asFound"=>"Glioblastoma", "relevance"=>"HIGH"}, {"id"=>"M9020", "name"=>"Glioma", "asFound"=>"Glioma", "relevance"=>"HIGH"}, {"id"=>"M5209", "name"=>"Brain Neoplasms", "relevance"=>"LOW"}, {"id"=>"M4561", "name"=>"Astrocytoma", "relevance"=>"LOW"}, {"id"=>"M20446", "name"=>"Neoplasms, Neuroepithelial", "relevance"=>"LOW"}, {"id"=>"M19845", "name"=>"Neuroectodermal Tumors", "relevance"=>"LOW"}, {"id"=>"M20388", "name"=>"Neuroectodermal Tumors, Primitive", "relevance"=>"LOW"}, {"id"=>"M12318", "name"=>"Neoplasms, Germ Cell and Embryonal", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12325", "name"=>"Neoplasms, Nerve Tissue", "relevance"=>"LOW"}, {"id"=>"T2518", "name"=>"Glioblastoma", "asFound"=>"Glioblastoma", "relevance"=>"HIGH"}, {"id"=>"T2519", "name"=>"Glioma", "asFound"=>"Glioma", "relevance"=>"HIGH"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DEVICE_FEASIBILITY", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>10}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2029-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-12", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2029-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of Successful Neuropixels Probe Recordings During Glioma Surgeries", "timeFrame"=>"From the beginning to end of tumor surgery", "description"=>"Description:\n\nThe primary outcome measure is the number of successful Neuropixels depth electrode recordings achieved during glioma surgeries. Success is defined as:\n\nSterility: No postoperative infections, assessed by clinical follow-up and microbiological testing.\n\nSignal Quality: Signal-to-noise ratio (SNR) above 30 dB, as measured during and after surgery through electrophysiological software.\n\nDevice Integrity: No fractures or damage to the Neuropixels probe, verified by post-procedure inspection.\n\nTraining Efficiency: Setup time and error reduction during the recording process, recorded across surgeries to assess team proficiency."}], "secondaryOutcomes"=>[{"measure"=>"Prognostic Biomarker Identification (Unit: Number of Isolated Single Neurons with Tumor-Modulated Activity):", "timeFrame"=>"From the beginning to end of surgery", "description"=>"The secondary outcome will focus on identifying prognostic biomarkers through intra-operative recordings using Neuropixels. This includes measuring the number of single neurons isolated with distinct spiking or waveform characteristics that correlate with tumor pathology. The outcome will be quantified as the number of neurons showing unique tumor-related activity patterns (e.g., altered firing rates, waveform morphology) across patients undergoing surgery."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Glioma", "Glioblastoma (GBM)", "Brain Tumor-Glioma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"37697108", "type"=>"BACKGROUND", "citation"=>"Coughlin B, Munoz W, Kfir Y, Young MJ, Meszena D, Jamali M, Caprara I, Hardstone R, Khanna A, Mustroph ML, Trautmann EM, Windolf C, Varol E, Soper DJ, Stavisky SD, Welkenhuysen M, Dutta B, Shenoy KV, Hochberg LR, Mark Richardson R, Williams ZM, Cash SS, Paulk AC. Modified Neuropixels probes for recording human neurophysiology in the operating room. Nat Protoc. 2023 Oct;18(10):2927-2953. doi: 10.1038/s41596-023-00871-2. Epub 2023 Sep 11."}, {"pmid"=>"35102333", "type"=>"BACKGROUND", "citation"=>"Paulk AC, Kfir Y, Khanna AR, Mustroph ML, Trautmann EM, Soper DJ, Stavisky SD, Welkenhuysen M, Dutta B, Shenoy KV, Hochberg LR, Richardson RM, Williams ZM, Cash SS. Large-scale neural recordings with single neuron resolution using Neuropixels probes in human cortex. Nat Neurosci. 2022 Feb;25(2):252-263. doi: 10.1038/s41593-021-00997-0. Epub 2022 Jan 31."}, {"pmid"=>"35679860", "type"=>"BACKGROUND", "citation"=>"Chung JE, Sellers KK, Leonard MK, Gwilliams L, Xu D, Dougherty ME, Kharazia V, Metzger SL, Welkenhuysen M, Dutta B, Chang EF. High-density single-unit human cortical recordings using the Neuropixels probe. Neuron. 2022 Aug 3;110(15):2409-2421.e3. doi: 10.1016/j.neuron.2022.05.007. Epub 2022 Jun 8."}, {"pmid"=>"38093008", "type"=>"BACKGROUND", "citation"=>"Leonard MK, Gwilliams L, Sellers KK, Chung JE, Xu D, Mischler G, Mesgarani N, Welkenhuysen M, Dutta B, Chang EF. Large-scale single-neuron speech sound encoding across the depth of human cortex. Nature. 2024 Feb;626(7999):593-602. doi: 10.1038/s41586-023-06839-2. Epub 2023 Dec 13."}, {"pmid"=>"37138086", "type"=>"BACKGROUND", "citation"=>"Krishna S, Choudhury A, Keough MB, Seo K, Ni L, Kakaizada S, Lee A, Aabedi A, Popova G, Lipkin B, Cao C, Nava Gonzales C, Sudharshan R, Egladyous A, Almeida N, Zhang Y, Molinaro AM, Venkatesh HS, Daniel AGS, Shamardani K, Hyer J, Chang EF, Findlay A, Phillips JJ, Nagarajan S, Raleigh DR, Brang D, Monje M, Hervey-Jumper SL. Glioblastoma remodelling of human neural circuits decreases survival. Nature. 2023 May;617(7961):599-607. doi: 10.1038/s41586-023-06036-1. Epub 2023 May 3."}, {"pmid"=>"35914528", "type"=>"BACKGROUND", "citation"=>"Venkataramani V, Yang Y, Schubert MC, Reyhan E, Tetzlaff SK, Wissmann N, Botz M, Soyka SJ, Beretta CA, Pramatarov RL, Fankhauser L, Garofano L, Freudenberg A, Wagner J, Tanev DI, Ratliff M, Xie R, Kessler T, Hoffmann DC, Hai L, Dorflinger Y, Hoppe S, Yabo YA, Golebiewska A, Niclou SP, Sahm F, Lasorella A, Slowik M, Doring L, Iavarone A, Wick W, Kuner T, Winkler F. Glioblastoma hijacks neuronal mechanisms for brain invasion. Cell. 2022 Aug 4;185(16):2899-2917.e31. doi: 10.1016/j.cell.2022.06.054. Epub 2022 Jul 31."}, {"pmid"=>"31534219", "type"=>"BACKGROUND", "citation"=>"Venkataramani V, Tanev DI, Strahle C, Studier-Fischer A, Fankhauser L, Kessler T, Korber C, Kardorff M, Ratliff M, Xie R, Horstmann H, Messer M, Paik SP, Knabbe J, Sahm F, Kurz FT, Acikgoz AA, Herrmannsdorfer F, Agarwal A, Bergles DE, Chalmers A, Miletic H, Turcan S, Mawrin C, Hanggi D, Liu HK, Wick W, Winkler F, Kuner T. Glutamatergic synaptic input to glioma cells drives brain tumour progression. Nature. 2019 Sep;573(7775):532-538. doi: 10.1038/s41586-019-1564-x. Epub 2019 Sep 18."}]}, "descriptionModule"=>{"briefSummary"=>"INTRODUCTION AND RATIONALE\n\nAggressive 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.\n\nThis 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.\n\nSTUDY AIM\n\nThe 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"90 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age between 18 yrs and 90 yrs old with radiologically diagnosed GBM\n* Eligible for surgery according to standard practices. If suitable and necessary according to standard practices, awake surgery is also permitted.\n* Written Informed consent.\n\nExclusion Criteria:\n\n* Inability to give consent because of or language barrier\n* Psychiatric history\n* Previous brain tumour surgery or radiotherapy\n* Severe aphasia or dysphasia\n* Patient has pacemaker or other implanted electrical device such as vagal nerve stimulator or other"}, "identificationModule"=>{"nctId"=>"NCT06617208", "acronym"=>"PIONEER", "briefTitle"=>"Prognostic IntraOperative Biomarkers IdeNtification in Tumor RElatEd SuRgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Erasmus Medical Center"}, "officialTitle"=>"Prognostic IntraOperative Biomarkers IdeNtification in Tumor RElatEd SuRgery (PIONEER Study)", "orgStudyIdInfo"=>{"id"=>"PaNaMa 12744"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Neuropixel probe recording", "description"=>"Cortical electrophysiology using the Neuropixel probe is performed to record brain activity in the peritumoral cortex", "interventionNames"=>["Device: Neuropixel probe recording"]}], "interventions"=>[{"name"=>"Neuropixel probe recording", "type"=>"DEVICE", "otherNames"=>["laminar electrophysiology", "cortical depth electrophysiology"], "description"=>"Neuropixel recordings captures neuronal activity at the single-neuron level across the layers of the cortex.", "armGroupLabels"=>["Neuropixel probe recording"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Koen van der Kuil", "role"=>"CONTACT", "email"=>"k.vanderkuil@erasmusmc.nl", "phone"=>"+31641078801"}, {"name"=>"Arnaud Vincent, MD PhD", "role"=>"CONTACT", "email"=>"a.vincent@erasmusmc.nl"}], "overallOfficials"=>[{"name"=>"Oscar Eelkman Rooda, MD PhD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Erasmus Medical Center"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Erasmus Medical Center", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"PhD Student", "investigatorFullName"=>"Koen van der Kuil", "investigatorAffiliation"=>"Erasmus Medical Center"}}}}
