Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 6:06 PM
Study NCT ID:
NCT04566367
Status:
UNKNOWN
Last Update Posted:
2023-07-13
First Post:
2018-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "The participants don't know which arm they were allocated to."}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2018-12-02', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of a second cancer or precancerous lesions', 'timeFrame': 'The time frame is during the PEG insertion (approximately 15min)', 'description': 'The detection rates for malignant or premalignant lesions in participants with head neck tumors will be compared when using BLI and white light endoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal cancer', 'Blue laser imaging', 'percutaneous endoscopic gastrostomy', 'head neck cancer'], 'conditions': ['Head Neck Cancer', 'Esophageal Cancer', 'Gastrostomy']}, 'descriptionModule': {'briefSummary': 'This study wants to focus on Carcinoma detection rates with blue laser imaging (BLI) for participants with head-neck cancer who need a percutaneous endoscopic gastrostomy (PEG). BLI is a new imaging technique that can easily be used within a standard gastroscopy.', 'detailedDescription': 'Head-Neck cancers are a significant burden all around the world. Patients suffering from one tumor are at high risk for a second cancer or another precancerous lesion. Before or during cancer treatment a PEG is needed to maintain a sufficient calories intake. PEG is established by performing a standard gastroscopy.\n\nThis randomised study wants to compare the detection rates of standard white light endoscopy compared to the additional use of blue laser imaging for second cancers or precancerous lesions in participants presenting for PEG establishment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants with the need of PEG due to head neck cancers or esophageal carcinoma\n\nExclusion Criteria:\n\n* Minors, pregnant women, contraindication for endoscopy, contraindications for establishment of a PEG'}, 'identificationModule': {'nctId': 'NCT04566367', 'briefTitle': 'Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Detection Rate by Blue Laser Imaging (BLI) of Secondary or Early Squamous Head and Neck Cancer in Patients Undergoing Elective Percutaneous Endoscopic Gastrostomy (PEG)', 'orgStudyIdInfo': {'id': 'JWGUHMED1-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard White Light Imaging', 'description': 'In this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy.', 'interventionNames': ['Diagnostic Test: blue laser imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Blue Light Imaging', 'description': 'In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy.', 'interventionNames': ['Diagnostic Test: blue laser imaging']}], 'interventions': [{'name': 'blue laser imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.', 'armGroupLabels': ['Blue Light Imaging', 'Standard White Light Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Klinikum der J. W. Goethe-Universität', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Mireen Friedrich-Rust, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georg Dultz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Record Keeper', 'investigatorFullName': 'Georg Dultz', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}