Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT06029504
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014846', 'term': 'Vulvar Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014845', 'term': 'Vulvar 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': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2023-09-01', 'studyFirstSubmitQcDate': '2023-09-01', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sentinel Node detection rate', 'timeFrame': 'Three years', 'description': 'SN detection rate with ICG and 99mTc-Nanocoll alone perioperatively, where lymphoscintigraphy is blinded, in patients with vulvar cancer (tumor \\< 4 cm) without clinical suspicion of metastases to the inguinal lymph nodes.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity, specificity, PPV and NPV', 'timeFrame': 'Three years', 'description': 'Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FDG PET-CT and US combined with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in the groins'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vulvar Cancer', 'Sentinel Lymph Node']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor \\< 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor \\< 4 cm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with primary or recurrent vulva cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary vulva cancer, FIGO stage IB (tumor \\< 4 cm)\n* Patients with unifocal recurrence in the vulva (tumor \\< 4 cm) located on the side where the patient is surgically naïve in the groin\n\nExclusion Criteria:\n\n* Prior irradiation of the vulva or groins\n* Prior SNB or inguinal lymphadenectomy in the relevant groin\n* Known allergy to ICG or iodine (ICG contains 5% sodium iodine)'}, 'identificationModule': {'nctId': 'NCT06029504', 'acronym': 'SENTIVUC', 'briefTitle': 'Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer', 'orgStudyIdInfo': {'id': 'H-18020235'}}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ligita P Frøding', 'role': 'CONTACT', 'email': 'ligita.paskeviciute.froeding@regionh.dk', 'phone': '+4522722972'}], 'facility': 'Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Ligita P Frøding', 'role': 'CONTACT', 'email': 'ligita.paskeviciute.froeding@regionh.dk', 'phone': '+4522722972'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ligita Paskeviciute Froding', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}