Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-05 @ 5:40 PM
Study NCT ID:
NCT04400292
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2020-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077258', 'term': 'sarcolipin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This will be a prospective single-arm study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of lymph nodes visualized to be fluorescent and nonfluorescent.', 'timeFrame': '1 year', 'description': 'Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Sentinel Lymph Node Mapping', 'lymphadenectomy', 'esophagectomy', 'ICG Injection', 'Intraoperative NIR Imaging', '20-201'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether sentinel lymph node (SLN) mapping with ICG dye and NIR imaging can be used to identify esophageal or esophagogastric junction cancer that has spread to the lymph nodes. If SLN mapping is successful in these types of cancer, surgeons in the future could identify the sentinel lymph nodes and only remove these instead of removing all the lymph nodes which is currently done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological diagnosis of adenocarcinoma tumor located in distal 1/3 of esophagus or esophagogastric junction , with a plan to undergo minimally invasive esophagectomy.\n* All patients with Stage IVA (AJCC Cancer Staging Manual, 8th edition) disease will be eligible\n* ≥18 years of age.\n* Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study and for standard surgical resection.\n\nExclusion Criteria:\n\n* No plan to undergo surgical resection.\n* Severe iodide or seafood allergy.\n* Women of childbearing potential without a negative pregnancy test; or women who are lactating.\n* Prior diagnosis of severe hepatic or renal dysfunction.\n* Patients with Stage IVB or M1 disease (AJCC Cancer Staging Manual, 8th edition)\n* Patients with local recurrence and planning to undergo salvage esophagectomy'}, 'identificationModule': {'nctId': 'NCT04400292', 'briefTitle': 'Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Does the Concept of the Sentinel Lymph Node Apply to Esophageal Cancer? A Prospective Assessment of Near-infrared Image-guided Lymphatic Mapping and Sentinel Lymph Node Identification in Esophageal Cancer', 'orgStudyIdInfo': {'id': '20-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLN mapping by NIR with ICG', 'description': 'Patients will undergo ICG injection and NIR imaging for lymphatic mapping. Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy. The SLN biopsy procedure will be performed as described below. Although NIR with ICG is used to assess conduit perfusion in all esophagectomies performed at MSK, its use for lymphatic mapping is considered experimental in esophageal cancer.', 'interventionNames': ['Other: Injection of indocyanine green (ICG)dye', 'Device: Near-Infrared Image-Guided', 'Procedure: Sentinel Lymph Node (SLN) mapping']}], 'interventions': [{'name': 'Injection of indocyanine green (ICG)dye', 'type': 'OTHER', 'description': 'Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.', 'armGroupLabels': ['SLN mapping by NIR with ICG']}, {'name': 'Near-Infrared Image-Guided', 'type': 'DEVICE', 'description': 'Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.', 'armGroupLabels': ['SLN mapping by NIR with ICG']}, {'name': 'Sentinel Lymph Node (SLN) mapping', 'type': 'PROCEDURE', 'description': 'Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.', 'armGroupLabels': ['SLN mapping by NIR with ICG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activities)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Daniela Molena, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}