Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT06906705
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar 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'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-03-26', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of HFUS Accuracy in Detecting Lymph Node Metastases in Gynecological Cancer', 'timeFrame': 'Days 20', 'description': 'The aim of this prospective trial is to report the sensivity, specificity, NPV, PPV and accuracy of HFUS in the metastasis detection (macro, micro and ITCs) from fresh, unstained ex vivo/in vivo lymph node samples.'}], 'secondaryOutcomes': [{'measure': 'Minimum Size Detection Limit of HFUS Imaging', 'timeFrame': '2 minutes', 'description': 'To assess the lowest size detectable with the adopted imaging technique'}, {'measure': 'Development of a Radiomic Algorithm for Lymph Node Assessment', 'timeFrame': '6 months', 'description': 'To develop a radiomic algorithm for the assesment of the lymphn node status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovarian cancer', 'endometrial cancer', 'cervical cancer', 'vulvar cancer', 'HFUS'], 'conditions': ['Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': 'Lymph node assessment is crucial in gynecological cancers (ovarian, endometrial, cervical, and vulvar), as nodal involvement significantly impacts prognosis and treatment. Despite high morbidity, systematic lymphadenectomy has been widely used for staging and treatment planning. However, in most cases, lymph nodes are free from metastasis, making the procedure unnecessary and exposing patients to severe complications such as lymphedema and infections.\n\nSentinel lymph node (SLN) evaluation has emerged as a less invasive alternative, reducing unnecessary lymphadenectomies. However, SLN techniques face challenges, including detection failures, inaccurate frozen section analysis, and imaging limitations like false negatives in FDG PET/CT scans. The need for improved intraoperative imaging techniques is emphasized to enhance lymph node assessment, minimize surgical risks, and better tailor treatment approaches.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to the Gynecology Oncology Unit in Fondazione Policlinico A. Gemelli\n\nIRCCS, Italy, Rome with a diagnosis of gynecological malignancy requiring surgical lymph nodes harvest will be evaluated for the enrolment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer)\n* Need for nodal excision (staging or cytoreductive reasons)\n* 18-99 years old\n* Absence of contemporary lymphatic diseases\n* Absence of previous oncological disease in the last 5 years\n* Willingness to participate in the study and to provide informed consent\n\nExclusion Criteria:\n\n* Previous radiotherapy treatments\n* Previous chemotherapy treatments'}, 'identificationModule': {'nctId': 'NCT06906705', 'acronym': 'RHINOCERUS', 'briefTitle': 'High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'High Frequency Ultrasound Imaging for Intraoperative Lymph Nodal Assessment in Gynecological Cancer: From Image-guided Surgery to Radiomics Applications', 'orgStudyIdInfo': {'id': '7480'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'ANTONIA CARLA TESTA, Professor', 'role': 'CONTACT', 'email': 'antoniacarla.testa@policlinicogemelli.it'}, {'name': 'Elena Teodorico, Dr', 'role': 'CONTACT', 'email': 'elena.teodorico@policlinicogemelli.it'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Antonia Carla Testa, Professor', 'role': 'CONTACT', 'email': 'antoniacarla.testa@policlinicogemelli.it', 'phone': '0630156399'}, {'name': 'Elena Teodorico', 'role': 'CONTACT', 'email': 'elena.teodorico@guest.policlinicogemelli.it'}], 'overallOfficials': [{'name': 'Antonia Carla Testa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canon Medical Systems Europe B.V', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}