Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04959604
Status:
RECRUITING
Last Update Posted:
2023-05-23
First Post:
2021-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lymph Node Mapping Via Flourescent Dye in Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intervention group. Participants will receive a state of the art surgical procedure with additional lymph node mapping'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-21', 'studyFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2021-07-10', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour', 'timeFrame': 'intraoperative assessment', 'description': 'Counting ICG-positive sites intraoperatively'}, {'measure': 'Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour', 'timeFrame': 'video-analysis within one week after surgery', 'description': 'Counting ICG-positive sites video-analysis'}, {'measure': 'Number of ICG-positive lymph nodes after endoscopic marking of the tumour', 'timeFrame': 'within one week after surgery', 'description': 'Picking ICG-positive lymph nodes ex vivo in unfixed specimen, sending ICG positive nodes separately to pathological examination'}, {'measure': 'Correlation of nodal-positive lymph nodes inside/outside the standard resection area', 'timeFrame': 'within one week after surgery', 'description': 'ICG-positive sites outside standard resection area will be "cherry picked", sent to pathological examination separatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['indocyanine green', 'lymphatic mapping', 'fluorescence'], 'conditions': ['Colon Carcinoma', 'Lymph Node Metastases']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative.\n\nThe draining lymph nodes will be visualized using the fluorescent dye indocyanine green.\n\nThe aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative.\n\nThe draining lymph nodes will be visualized using the fluorescent dye indocyanine green.', 'detailedDescription': 'Participants with a diagnosed (andeno)carcinoma of the ascending, transverse, descending and sigmoid colon will be included. Preoperatively the participants will receive an indocyanine green(ICG) injection at four points around the tumour endoscopically. The ICG marking will take place one to five days prior to surgery. In the draining lymph nodes of the specific region the ICG will accumulate and thus visible via fluorescence-camera during the surgery.\n\nIntraoperatively, the precise locations of all fluorescent nodes will be documented photographically. A standard resection and lymph node dissection will be conducted, potential fluorescent nodes outside the standard resection lines will additionally be resected. The fresh specimen will then be measured, the fluorescent nodes marked and after the pathologic examination the nodes will be correlated to location, fluorescent yes/no and nodal positive/negative.\n\nThe aim ist not the visualization of the Sentinel node or the directly draining lymphatic vessel but all the nodes draining the peritumorous region at the point of surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.\n\nExclusion Criteria:\n\n* not wanting to participate\n* other carcinoma then adenocarcinoma\n* endoscopic marking not possible'}, 'identificationModule': {'nctId': 'NCT04959604', 'briefTitle': 'Lymph Node Mapping Via Flourescent Dye in Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application', 'orgStudyIdInfo': {'id': 'CCLNM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICG-marked Colon Carcinoma', 'description': 'The participants will receive an endoscopic marking via ICG preoperatively', 'interventionNames': ['Procedure: ICG-marking endoscopically']}], 'interventions': [{'name': 'ICG-marking endoscopically', 'type': 'PROCEDURE', 'description': 'Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.', 'armGroupLabels': ['ICG-marked Colon Carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Julia-Kristin Grass, Dr.', 'role': 'CONTACT', 'email': 'j.grass@uke.de'}], 'facility': 'University of Hamburg Medical Institutions', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Katharina L Lucas, MD', 'role': 'CONTACT', 'email': 'katharina.lucas@uni-wh.de', 'phone': '+4915779600815'}, {'name': 'Julia-Kristin Grass, Dr.', 'role': 'CONTACT', 'email': 'j.grass@uke.de', 'phone': '+4915222815011'}], 'overallOfficials': [{'name': 'Daniel Perez, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of General Visceral and Thoracic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Available on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}