Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-30 @ 12:15 AM
Study NCT ID:
NCT04668261
Status:
RECRUITING
Last Update Posted:
2020-12-29
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.', 'timeFrame': '5 years', 'description': 'blood flow changes will be assessed with quantitative blood oxygenation-level dependent cerebrovascular reactivity measurements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Blood Flow Impairment']}, 'descriptionModule': {'briefSummary': 'Primary study objective:\n\n• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.\n\nSecondary study objectives:\n\n* Longitudinal observation of hemodynamic patterns versus structural brain tissue changes in neurosurgical patients.\n* Changes in blood flow patterns and structural brain tissue after neurosurgical interventions as compared to a healthy cohort.\n* Determining hemodynamic imaging patterns that can be tested as novel imaging markers.', 'detailedDescription': 'Primary study objective:\n\n• to study the longitudinal observation of brain blood flow changes in neurosurgical patients to evaluate the effect of surgical or conservative treatment on the brain structural and hemodynamic integrity.\n\nSecondary study objectives:\n\n* To observe the relationship between longitudinal changes in hemodynamic patterns and structural brain tissue changes in neurosurgical patients.\n* To determine different hemodynamic patterns that may be used as novel imaging biomarkers in future studies.\n\n4.2 Outcomes\n\nOutcomes of the project:\n\nPrimary endpoint:\n\nTo find correlation between course of disease, neurosurgical intervention and changes in brain blood flow and brain structure.\n\nSecondary endpoints:\n\n* Correlation between progression of disease and hemodynamic patterns over time (ie. novel imaging markers)\n* Correlation of clinical management (neurosurgical treatment vs. best medical care) and changes in brain blood flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neurosurgical patients with the potential to have altered blood flow to the brain', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria\n\nPatients:\n\n* Male and Female subjects \\>18 years of age\n* Written informed consent after participants' information. Foreign speaking patients should be accompanied by a person with sufficient German language proficiency to act as a translator\n* Neurosurgical diseases with the potential to alter blood flow to the brain:\n\n * Cerebrovascular disease\n * Brain tumors\n * Normal Pressure Hydrocephalus\n\nHealthy subjects:\n\n* Male and Female subjects \\>18 years of age\n* Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator\n\nExclusion criteria:\n\nPatients:\n\n* Unwilling or unable to co-operate with breathing maneuvers\n* Respiratory or cardiac limitations to breathing through a mask\n* Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis)\n* Standard contraindications for MRI scanning\n* Verbal confirmed pregnancy\n* Known multiple intracranial diseases\n* Presence of intracranial hemorrhage within the last 3 months\n* Symptomatic increased intracranial pressure\n\nHealthy subjects:\n\n* Unwilling or unable to co-operate with breathing maneuvers\n* Respiratory or cardiac limitations to breathing through a mask\n* Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis)\n* Standard contraindications for MRI scanning\n* Verbal confirmed pregnancy\n* Anamnesticly a history of neurological disease or current neurological deficits."}, 'identificationModule': {'nctId': 'NCT04668261', 'briefTitle': 'Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients', 'orgStudyIdInfo': {'id': '2020-02314'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neurosurgical patients', 'description': '• Neurosurgical diseases with the potential to alter blood flow to the brain:\n\n* Cerebrovascular disease\n* Brain tumors\n* Normal Pressure Hydrocephalus', 'interventionNames': ['Other: Advanced imaging investigation']}, {'label': 'Healthy subjects', 'description': '* Male and Female subjects \\>18 years of age\n* Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator', 'interventionNames': ['Other: Advanced imaging investigation']}], 'interventions': [{'name': 'Advanced imaging investigation', 'type': 'OTHER', 'description': 'MRI imaging', 'armGroupLabels': ['Healthy subjects', 'Neurosurgical patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Jorn Fierstra, MD, PhD', 'role': 'CONTACT', 'email': 'jorn.fierstra@usz.ch', 'phone': '0041 442553169'}, {'name': 'Luca Regli, Professor', 'role': 'CONTACT', 'email': 'Luca.regli@usz.ch', 'phone': '0041442552992'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}