Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 5:57 PM
Study NCT ID:
NCT04230603
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2020-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Characterization With Hyperspectral Imaging (HSI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081862', 'term': 'Hyperspectral Imaging'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-06-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor detection with HSI', 'timeFrame': 'direct during the Operation (ca. 15-20 Minutes)', 'description': 'Due to the non-invasive diagnostics with the HSI camera, tumor tissue can be distinguished from healthy tissue.'}, {'measure': 'Tissue recognition with HSI', 'timeFrame': 'after the operation within 24 hours', 'description': 'different tissues can be differentiated from each other with HSI'}, {'measure': 'Inflammatory classification with HSI', 'timeFrame': 'after the operation within 24 hours', 'description': 'Classification of the grade of the inflammation e.g. in IBD'}], 'secondaryOutcomes': [{'measure': 'Tissue perfusion', 'timeFrame': 'direct during the Operation (ca. 10-15 Minutes)', 'description': 'Tissue perfusion in the upper and lower tissue layers measured with the HSI Camera'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperspectral imaging', 'tissue detection', 'tumor detection', 'infammatory bowel disease', 'colorectal cancer'], 'conditions': ['Tissue Perfusion', 'Tumor', 'Inflammation', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'Hyperspectral Imaging (HSI) is a contact free method to analyse the from the tissue reflected light in the range of 500-1000nm. Aim of the study is to identify special reflex patterns to identify special tissue', 'detailedDescription': 'This HSI-camera provides hyperspectral images with a high spectral resolution (5 nm) in the visible and near infrared range (500-1000 nm). A RGB image and 4 false color images that represent physiologic parameters are intraoperatively provided by an analysis software. But after the procedure all spectral datasets could be investigated. To analyse and differentiate the different tissues, a catalog database is needed of all tissues including Tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with surgical procedure\n\nExclusion Criteria:\n\n* inability to consent'}, 'identificationModule': {'nctId': 'NCT04230603', 'acronym': 'HSIT', 'briefTitle': 'Tissue Characterization With Hyperspectral Imaging (HSI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Tissue Characterisation With Hyperspectral Imaging Methods', 'orgStudyIdInfo': {'id': '201905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperspectral imaging', 'description': 'diagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination', 'interventionNames': ['Procedure: Hyperspectral imaging', 'Diagnostic Test: Lactate acid measurement', 'Diagnostic Test: pathological examination']}], 'interventions': [{'name': 'Hyperspectral imaging', 'type': 'PROCEDURE', 'otherNames': ['Marking of the target region (Suture/Clip/ink)'], 'description': 'Photos were taken with the hyperspectral camera of the human tissue', 'armGroupLabels': ['Hyperspectral imaging']}, {'name': 'Lactate acid measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'At the marked regions of the specimen, a lactate acid measurement was performed.', 'armGroupLabels': ['Hyperspectral imaging']}, {'name': 'pathological examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'At the marked regions of the specimen, the pathological examination was performed.', 'armGroupLabels': ['Hyperspectral imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Boris Jansen-Winkeln, MD, PD', 'role': 'CONTACT', 'email': 'boris.jansen-winkeln@medizin.uni-leipzig.de', 'phone': '+49-341-97-', 'phoneExt': '17200'}, {'name': 'Ines Gockel, MD, Prof.', 'role': 'CONTACT', 'email': 'ines.gockel@medizin.uni-leipzig.de', 'phone': '+49-341-97-', 'phoneExt': '17200'}, {'name': 'Boris Jansen-Winkeln, MD, PD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Leipzig - AöR', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Boris Jansen-Winkeln, MD, PD', 'role': 'CONTACT', 'email': 'boris.jansen-winkeln@medizin.uni-leipzig.de', 'phone': '+49-314-97', 'phoneExt': '17200'}, {'name': 'Ines Gockel, MD, Prof.', 'role': 'CONTACT', 'email': 'ines.gockel@medizin.uni-leipzig.de', 'phone': '+49-314-97', 'phoneExt': '17200'}], 'overallOfficials': [{'name': 'Ines Gockel, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Boris Jansen-Winkeln', 'investigatorFullName': 'Dr. Boris Jansen-Winkeln', 'investigatorAffiliation': 'University of Leipzig'}}}}