Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT04051502
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2019-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2019-08-05', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods.', 'timeFrame': '1 year', 'description': 'Evaluate for dye uptake in the regional lymphatic channels, and in the pelvic and para-aortic nodes using infrared imaging.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ovarian Cancer', 'Adnexal Mass', 'Ovarian Sentinal Lymph Nodes', '19-271', 'Memorial Sloan Kettering Cancer Center', 'Sentinal Lymph Nodes', 'indocyanine green dye', 'ICG Dye'], 'conditions': ['Ovarian Cancer', 'Adnexal Mass']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out how well ovarian sentinel lymph nodes (SLNs) can be identified with indocyanine green (ICG) dye during risk-reducing ovarian surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing surgery with the Gynecology Service at MSK.\n* Women undergoing surgery for an adnexal mass without pre-operative suspicion of high stage disease, with or without a hysterectomy\n\n °For this protocol, "suspected high stage disease" will be defined as any patient with radiologic or clinical evidence of ovarian cancer which has spread outside of the ovary. Thus, only patients with an adnexal mass, or bilateral adnexal masses, are eligible.\n* Women in whom MIS surgery is converted to a laparotomy will not be excluded as both surgical approaches, MIS and open, will be utilized.\n* Women \\>/= 18 years of age\n* Able to provide informed consent\n* Albumin levels within normal range\n\nExclusion Criteria:\n\n* Current non-GYN primary malignancy\n* Prior or current history of uterine, cervical, peritoneal, or vulvovaginal malignancy\n* Ongoing anticancer therapy\n* Prior bilateral oophorectomy\n* Known severe anaphylactic iodide allergy\n* Known history of cirrhosis or other chronic liver disease, or women with hepatic dysfunction.\n* Elevated transaminases (ALT, AST) and/or Alk Phos will be evaluated by the treating physician on a case by case basis.'}, 'identificationModule': {'nctId': 'NCT04051502', 'briefTitle': 'ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study', 'orgStudyIdInfo': {'id': '19-271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'First group of 10 participants enrolled', 'interventionNames': ['Drug: Method 1: Indocyanine green dye']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Second group of 10 participants enrolled', 'interventionNames': ['Drug: Method 2: Indocyanine green dye']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Third group of 10 participants enrolled', 'interventionNames': ['Drug: Method 3: Indocyanine green dye']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Fourth group of 10 participants enrolled', 'interventionNames': ['Drug: Method 3: Indocyanine green dye']}], 'interventions': [{'name': 'Method 1: Indocyanine green dye', 'type': 'DRUG', 'otherNames': ['ICG dye'], 'description': 'Injection 4 mL of ICG dye directly into the fallopian tube (1 or more places is acceptable) only to the side where the adnexal mass is located', 'armGroupLabels': ['Group 1']}, {'name': 'Method 2: Indocyanine green dye', 'type': 'DRUG', 'otherNames': ['ICG dye'], 'description': '1mL of ICG injected at each of the four sites: only to the side where the adnexal mass is located\n\n* Dorsal side of the IP ligament\n* Ventral side of the IP ligament\n* Dorsal side of the utero-ovarian ligament\n* Ventral side of the utero-ovarian ligament', 'armGroupLabels': ['Group 2']}, {'name': 'Method 3: Indocyanine green dye', 'type': 'DRUG', 'otherNames': ['ICG dye'], 'description': 'Injection of 2mL of ICG dye into the IP ligament pedicle after the adnexal mass has been removed. Only to the side where the adnexal mass is located', 'armGroupLabels': ['Group 3']}, {'name': 'Method 3: Indocyanine green dye', 'type': 'DRUG', 'description': 'Injection of 2mL of ICG dye into the IP ligament pedicle before the adnexal mass is removed.', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Basking Ridge (Consent only)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Monmouth (Consent only)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Bergen (Consent only )', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Commack (Consent only)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester (Consent only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Nassau (Consent only)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'overallOfficials': [{'name': 'Ginger Gardner, 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'}}}}