Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 8:06 AM
Study NCT ID:
NCT06161428
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2023-11-29', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'Three years', 'description': 'Sensitivity of sentinel lymph node mapping'}], 'secondaryOutcomes': [{'measure': 'Negative predictive value', 'timeFrame': 'Three years', 'description': 'Negative predictive value of sentinel lymph node mapping'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vulva Cancer', 'Sentinel Lymph Node']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with vulva cancer tumour size \\>4 cm, multifocal tumors and local recurrences.'}, '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 vulva cancer, tumor \\> 4 cm, multifocal tumor, or local recurrences in vulva\n\nExclusion Criteria:\n\n* Previous external irradiation of the vulva or groins\n* Former sentinel node or inguinal lymphadenectomy in the relevant groin\n* Known allergy to ICG or iodine\n* Patient is in active treatment for other cancer and/or disseminated disease'}, 'identificationModule': {'nctId': 'NCT06161428', 'acronym': 'SENTIVUC II', 'briefTitle': 'Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)', 'orgStudyIdInfo': {'id': 'P-2022-946'}}, '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'}}}}