Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT00949793
Status:
COMPLETED
Last Update Posted:
2009-11-10
First Post:
2009-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Vivo Confocal Endomicroscopy of the Brain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-09', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test of the ability of the surgeon to obtain interpretable images during surgery.', 'timeFrame': 'During surgery'}], 'secondaryOutcomes': [{'measure': 'To correlate the in vivo endomicroscopy images with traditional histopathology.', 'timeFrame': 'one week'}, {'measure': 'To evaluate the usability of the device in the OR environment.', 'timeFrame': 'During surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pathology', 'Microscopy, Confocal', 'Microscopy, Fluorescence', 'Intraoperative Procedures'], 'conditions': ['Brain Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test the feasibility of obtaining interpretable in vivo endomicroscopy images which can be compared with traditional histopathology.\n\nHypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables differentiation of tumour tissue from normal adjacent brain tissue.', 'detailedDescription': 'Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. It is already in clinical use in the fields of gastroenterological endoscopy, laparoscopy, dermatology, gynecology and respiratory medicine. This study represents the first time that confocal endomicroscopy will be evaluated for intraoperative imaging in neurosurgery.\n\nThe procedure involves a small endoscope which is placed gently into contact with the brain, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. The captured confocal images will be compared with corresponding histology (tissue that is being removed as part of the indicated neurosurgical procedure). The images will be visually compared among each other and with histology images to detect possible clinically relevant information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy.\n\nExclusion Criteria:\n\n* Pregnant women\n* Inability to give informed consent\n* History of allergy to fluorescein\n* Patients on beta-blockers or ACE inhibitors'}, 'identificationModule': {'nctId': 'NCT00949793', 'briefTitle': 'In Vivo Confocal Endomicroscopy of the Brain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carl Zeiss Surgical GmbH'}, 'officialTitle': 'In Vivo Confocal Endomicroscopy of the Brain', 'orgStudyIdInfo': {'id': '002441'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All patients', 'interventionNames': ['Device: Endomicroscope']}], 'interventions': [{'name': 'Endomicroscope', 'type': 'DEVICE', 'description': 'Endomicroscopic images are taken at several positions on the tumor.', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Barrow Neurological Institute, St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Peter Nakaji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Barrow Neurological Institute, St. Joseph's Hospital and Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Zeiss Surgical GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Gerhard Gaida / Clinical Affairs', 'oldOrganization': 'Carl Zeiss Surgical GmbH'}}}}