Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-11 @ 12:50 PM
Study NCT ID:
NCT02027818
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2014-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000072662', 'term': 'Margins of Excision'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2014-01-02', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- Evaluation of the ability of NIR imaging to show (fluorescent) the tumoral volumes, the tumoral tissues to be analyzed by the pathologist, especially at the level of the operative margins', 'timeFrame': '17 months'}], 'secondaryOutcomes': [{'measure': '- Analysis of the correlation between (levels of) ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist', 'timeFrame': '17 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['margins', 'tumorectomy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent', 'detailedDescription': 'In the operating room:\n\nICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.\n\nThe surgeon will remove the tumour (and the axillary lymph nodes) as usual.\n\nOptionally, peroperative "in vivo" imaging of the dissection of the tumour using the PDE camera will be performed.\n\nIn the Laboratory of Pathology:\n\nThe "fresh" tumorectomy piece will be processed as usual, and the thick sections for the evaluation of the margins as well as the tissues samples from each margins will be imaged using the PDE in comparison with the fluorescence in the mid part of the tumour and the fluorescent areas will be so delimited (and later analyzed in comparison with standards of known fluorescence intensity).\n\nAfter fixation, the tumoral tissues will be thereafter processed "as usual".\n\nIf fluorescent foci are identified at the level of the axillary piece (in case of CALND), they will be dissected and processed as other lymph nodes. Additionally, metastatic lymph nodes -if present- will also be controlled for their microscopic fluorescence or not.\n\nUsing the near-infrared fluorescence microscope, the slides corresponding to the macroscopically fluorescent structures will be analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection,\n* Informed consent form signed.\n\nExclusion Criteria:\n\n* Diagnosis of mammary cancer established by "gross" biopsy,\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).\n* During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).\n* Pregnancy, breastfeeding'}, 'identificationModule': {'nctId': 'NCT02027818', 'briefTitle': 'Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'officialTitle': 'Study of the (Intravenously Injected) Indocyanine Green Distribution in the Margins of Breast Cancer After Tumorectomy', 'orgStudyIdInfo': {'id': 'BR-TUM-ICG-IV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indocyanine Green', 'description': 'study of the correlation between fluorescence and margins of the tumours after iv injection of Indocyanine Green', 'interventionNames': ['Drug: Indocyanine Green']}], 'interventions': [{'name': 'Indocyanine Green', 'type': 'DRUG', 'otherNames': ['ICG'], 'description': 'Observation of the correlation between fluorescence and margins of the tumour after IV injection of ICG', 'armGroupLabels': ['Indocyanine Green']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Jules Bordet Institute', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Danièle Noterman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jules Bordet Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}