Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT05937620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-18
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Global detection rate of sentinel lymph node in patients having received both tracers.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by morphologic characteristics.'}, {'measure': 'Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by pathology results'}, {'measure': 'Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to International Federation of Gynecology and Obstetrics (FIGO) stage', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by FIGO stage'}, {'measure': 'Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by biochemistry results'}, {'measure': 'Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by surgical approach'}, {'measure': 'Evaluation of anatomical distribution of 99mTC draining', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer'}, {'measure': 'Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative detector gamma probe,stratified by morphologic characteristics.'}, {'measure': 'Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative detector gamma probe,stratified by pathology results.'}, {'measure': 'Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative detector gamma probe,stratified by FIGO stage.'}, {'measure': 'Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative detector gamma probe,stratified by biochemistry results.'}, {'measure': 'Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative detector gamma probe,stratified by surgical approach.'}, {'measure': 'Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative NIR camera,stratified by morphological characteristics'}, {'measure': 'Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative NIR camera,stratified by pathology results.'}, {'measure': 'Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative NIR camera,stratified by FIGO stage.'}, {'measure': 'Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative NIR camera,stratified by biochemistry results.'}, {'measure': 'Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Detection rate and false negative rate of intraoperative NIR camera,stratified by surgical approach.'}, {'measure': 'Anatomical distribution of sentinel lymph node detected with ICG.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Anatomical location of sentinel lymph node according to ICG.'}, {'measure': 'Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Anatomical location of sentinel lymph node according to 99mTC albumin nanocolloid.'}, {'measure': 'Comparison of lymph node detection with both tracers.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Assessment of concordance of sentinel lymph node anatomical location detected with each tracer.'}, {'measure': 'Evaluation of ultra-staging in micrometastases detection compared to conventional histology.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Pathology ultra-staging evaluation.\n\nThe following classification will be considered according to the criteria of the American Joint Committee on Cancer (AJCC):\n\n* Macrometastases: tumor infiltration \\> 2 mm in maximum diameter.\n* Micrometastases: tumor infiltration between 0.2 and 2 mm in maximum diameter.\n* Isolated tumor cells or isolated cell group (CTA, GCA): clusters of cells smaller than 0.2 mm'}, {'measure': 'Evaluation of the complications associated with each technique.', 'timeFrame': 'Through study completion (an average of 36 months)', 'description': 'Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Epithelial Cancer']}, 'descriptionModule': {'briefSummary': 'Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.\n* Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.\n* Signing of informed consent by the patient or relative in charge.\n* Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).\n\nExclusion Criteria:\n\n* Patients \\<18 years\n* Pregnancy or breastfeeding\n* Epithelial ovarian tumors stage FIGO III or IV.\n* Impossibility to obtain a biopsy from the tumor.\n* History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.\n* Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology.\n* Patient not able to undergo surgery.\n* Hypersensitivity to active principle, to sodium iodide or iodine allergy.\n* Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland'}, 'identificationModule': {'nctId': 'NCT05937620', 'acronym': 'Melisa-II', 'briefTitle': 'Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinic per a la Recerca Biomédica'}, 'officialTitle': 'Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study', 'orgStudyIdInfo': {'id': '2023-505667-37-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional arm', 'description': 'All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin', 'interventionNames': ['Diagnostic Test: 99mTC nanocolloid albumin injection', 'Diagnostic Test: ICG injection']}], 'interventions': [{'name': '99mTC nanocolloid albumin injection', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients will receive an injection of both tracers in order to detect the sentinel lymph node', 'armGroupLabels': ['Interventional arm']}, {'name': 'ICG injection', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients will receive an injection of both tracers in order to detect the sentinel lymph node', 'armGroupLabels': ['Interventional arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Laura Burunat, Graduate', 'role': 'CONTACT', 'email': 'burunat@recerca.clinic.cat', 'phone': '932275400', 'phoneExt': '4198'}], 'overallOfficials': [{'name': 'Berta Diaz-Feijoo, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}, {'name': 'Aureli Torné, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}