Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT01834469
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2013-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging of Peritoneal Carcinomatosis From Ovarian Carcinoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010534', 'term': 'Peritoneal Neoplasms'}, {'id': 'D007725', 'term': 'Krukenberg Tumor'}], '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': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D018279', 'term': 'Carcinoma, Signet Ring Cell'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018297', 'term': 'Neoplasms, Cystic, Mucinous, and Serous'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-14', 'studyFirstSubmitDate': '2013-04-14', 'studyFirstSubmitQcDate': '2013-04-17', 'lastUpdatePostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma', 'timeFrame': '1 year', 'description': 'Evaluation of the feasibility of NIF imaging to detect tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma, the efficacy of this approach will be confirmed by histological test of the dissected tissue.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ovarian,metastasis'], 'conditions': ['Ovarian Cancer', 'Peritoneal Carcinomatosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if NIF fluorescent imaging is an effective approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer patients.', 'detailedDescription': 'Primary objective:\n\nEvaluation of the ability of NIR imaging to image and to detect the " viable " gross tumoral mass and/or peritoneal metastatic " implants " in women operated for ovarian carcinoma with peritoneal carcinomatosis after the IV injection of ICG ( which is approved for human use) the day before the operation.\n\nSecondary objective:\n\nDefinition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (and, if any is demonstrated pre-operatively, in the nodes of these patients found fluorescent and removed).\n\nhowever other goals of our project will be will be:\n\n* to confirm that all dissected fluorescent tissue samples are malignant by histopathology.\n* to study the histological distribution of ICG in these tumoral tissues.\n* to investigate if there is any other florescent tissue in the peritoneal areas which surgeons could not detect any visible tumor implants.\n* to distinguish by ICG distribution in between viable tumor tissue from fibrosis and necrosis caused by chemotherapy which is normally difficult to be defined in scars which are routinely removed, but if we could identify the viable tumor tissue by NIF imaging in the operation room, surgeons can avoid dissecting benign scars in the future.\n\nHopefully ICG will be able to help, firstly, in the scoring of the peritoneal cancer index (PCI) enhancing the detection of small nodules which were undetected by normal visualization allowing a more \'complete\' surgical treatment of the disease and secondarily, in the staging of these patients with the potential to upgrade patients from stage I/II to stage III in cases where fluoroscopy would allow to detect unknown minimal peritoneal carcinomatosis.\n\nMethodology:\n\nThe day before the operation:\n\nICG 0.25 mg/kg will be given as an iv injection the day before the operation.\n\nIn the operating room:\n\nWhen the patient will be opened, the surgeons will (under "conventional" video control) search ("in an orderly fashion") and establish "as usual" the presence of "gross" tumoral mass, of metastatic deposits and of "scars" at the level of the peritoneal surfaces. NIR imaging will be acquired during these maneuvers and fluorescent structures and/or foci will be anatomically defined by the surgeons.\n\nThe operation will be then continued as usual but each anatomical piece will be controlled "ex vivo" for its fluorescent character or not. All fluorescent foci on these anatomical pieces will be identified as such by a mark and/or by a "suture".\n\nIf lymph nodes were suspected to be metastatic (for instance on the basis of the PET-CT with 18F-DG performed before surgery), they will be searched, (optionally controlled in vivo for their visibility using NIR camera)and dissected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (either newly diagnosed, or relapsing) with histo-pathological diagnosis of ovarian carcinoma and peritoneal carcinomatosis who are candidate for "open" surgery, either after neo-adjuvant chemotherapy (80-90% of the cases), or in "first intent".\n* Informed consent form signed.\n\nExclusion Criteria:\n\n* Age less than18 years old.\n* Inability to give informed consent.\n* History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.\n* Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.\n* Documented coronary disease.\n* Advanced renal impairment (creatinine \\> 1,5mg/dl).'}, 'identificationModule': {'nctId': 'NCT01834469', 'acronym': 'OV-AP-ICG-IV', 'briefTitle': 'Imaging of Peritoneal Carcinomatosis From Ovarian Carcinoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'officialTitle': 'Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma', 'orgStudyIdInfo': {'id': '2083'}, 'secondaryIdInfos': [{'id': '2013-000276-15', 'type': 'OTHER', 'domain': 'Federal Agency for medicine and health products'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ICG NIR imaging', 'description': 'see Summary and description iv injection of ICG', 'interventionNames': ['Drug: iv injection of ICG']}], 'interventions': [{'name': 'iv injection of ICG', 'type': 'DRUG', 'description': 'An iv injection will be performed for the ovarian cancer patient before the operation.', 'armGroupLabels': ['ICG NIR imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Jules Bordet Institute', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Isabelle Veys, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surgeon in Jules Bordet Institute'}, {'name': 'Gabriel Liberale, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Surgeon in Jules Bordet Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}