Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-29 @ 12:19 AM
Study NCT ID:
NCT04056260
Status:
UNKNOWN
Last Update Posted:
2020-03-20
First Post:
2019-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICG-NIR Guided Lymph Node Dissection in Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 219}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-19', 'studyFirstSubmitDate': '2019-08-11', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity and specificity', 'timeFrame': '1 month', 'description': 'sensitivity and specificity of ICG-NIR guided lymph node dissection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stomach Neoplasm']}, 'descriptionModule': {'briefSummary': 'As the survival rate of patients with gastric cancer has increased, there has been a growing interest in interventions that improve postoperative quality of life. Therefore minimally invasive surgery or endoscopic resection has been performed much more frequently. However, adequate lymph node dissection is important as well. The aim of the study is to identify the feasibility of indocyanine green - near infra-red (ICG-NIR) guided sentinel lymph node dissection for the treatment of gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dignosed gastric adenocarcinoma\n* tumor: size 4cm or smaller\n* depth of invasion: mucosa, submucosa, proper muscle\n* candidates of laparoscopic radical gastrectomy\n* informed consent\n\nExclusion Criteria:\n\n* metachronous malignancy\n* number of tumors: 2 or more\n* remnant gastric cancer\n* indication for endoscopic resection\n* history of chemotherapy or radiation therapy\n* pregnancy\n* allergy to ICG\n* metastatic gastric cancer'}, 'identificationModule': {'nctId': 'NCT04056260', 'briefTitle': 'ICG-NIR Guided Lymph Node Dissection in Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Oncologic Safety of Sentinel Lymph Node-guided Lymph Node Dissection Using ICG-NIR Laparoscopy in Gastric Cancer', 'orgStudyIdInfo': {'id': 'SDR-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICG injection', 'description': 'ICG 0.5mg/ml x 0.5ml x 4 sites', 'interventionNames': ['Procedure: ICG-NIR guided surgery']}], 'interventions': [{'name': 'ICG-NIR guided surgery', 'type': 'PROCEDURE', 'description': 'ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy', 'armGroupLabels': ['ICG injection']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ho Seok Seo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ho Seok Seo', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}