[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533555":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":66,"collaborators":36,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":36,"enrollmentInfo":77,"targetDuration":36,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":49,"whyStopped":36,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Jules Bordet Institute","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"0.125 mg\u002Fkg","EXPERIMENTAL","Patients who will be injected with 0.125 mg\u002Fkg Indocyanine green before their tumorectomy",[13],"Drug: Indocyanine green",{"label":15,"type":10,"description":16,"interventionNames":17},"0.25 mg\u002Fkg","Patients who will be injected with 0.25 mg\u002Fkg Indocyanine green before their tumorectomy",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"0.5 mg\u002Fkg","Patients who will be injected with 0.5 mg\u002Fkg Indocyanine green before their tumorectomy",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"1 mg\u002Fkg","Patients who will be injected with 1 mg\u002Fkg Indocyanine green before their tumorectomy",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"2 mg\u002Fkg","Patients who will be injected with 2 mg\u002Fkg Indocyanine green before their tumorectomy",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Indocyanine green","Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg\u002Fkg, 0.25 mg\u002Fkg, 05 mg\u002Fkg, 1 mg\u002Fkg, and 2 mg\u002Fkg) will be administrated by slow intravenous injection by peripheral venous catheter:\n\n* at induction anaesthesia of the surgical procedure (0.125 mg\u002Fkg or 0.25mg\u002Fkg), or\n* in the hospital room 24 hours before the breast surgery (05 mg\u002Fkg, or 1 mg\u002Fkg, or 2 mg\u002Fkg).",[9,15,19,23,27],null,[38],{"name":39,"affiliation":5,"role":40},"Florin Pop, MD","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","+322541","3244","catalin.florin.pop@hubruxelles.be",[48],{"facility":5,"status":49,"city":50,"state":36,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Brussels","1070","Belgium","BE",{"type":55,"coordinates":56},"Point",[57,58],4.34878,50.85045,{"lat":58,"lon":57},[61,62],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},{"name":63,"role":43,"phone":44,"phoneExt":64,"email":65},"Sophie Vankerckhove","7341","sophie.vankerckhove@hubruxelles.be",{"type":67,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100533555","icg-fluorescence-imaging-for-intraoperative-breast-cancer-margins-evaluation-a-dose-timing-study-100533555",false,"NCT06227338","ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study","BREASTIFLU-1","Inclusion Criteria:\n\n1. female;\n2. age of ≥18 years;\n3. histological diagnosis of ductal invasive breast cancer;\n4. a primary early-stage invasive breast cancer (cT1 and\u002For cT2, assessed clinically and\u002For radiologically), without prior BC surgery of the actually affected breast;\n5. ECOG Performance Status (PS) 0 or 1;\n6. signed informed consent form (ICF) obtained prior to any study related procedure.\n\nExclusion Criteria:\n\n1. advanced invasive breast cancer (cT3 and\u002For cT4);\n2. in situ breast cancer disease;\n3. lobular invasive breast cancer (at histology);\n4. invasive breast cancer treated by neoadjuvant chemotherapy and\u002For endocrine therapy;\n5. prior history of invasive or breast cancer of the actually affected breast in the past;\n6. history of allergy or hypersensitivity to investigational product (active substance or ingredients);\n7. history of allergy to iodine or to shellfish;\n8. have apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal, or disseminated autonomy of the thyroid gland;\n9. documented coronary disease\n10. advanced renal insufficiency (serum creatinine \\>1.5 mg\u002FdL);\n11. chronic liver disease with the Child-Pugh class B or C ;\n12. concurrent medication which reduces or increases the elimination of indocyanine green dye (ie, anticonvulsants, haloperidol, and heparin) during the 2 weeks before the expected operation;\n13. pregnant or lactating women;\n14. inability to give informed consent.","FEMALE","18 Years",{"count":78,"type":79},250,"ESTIMATED","INTERVENTIONAL",[82],"NA","Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment.\n\nTwo preoperatively times frames will be used for the administration of a total of 5 different indocyanine green (ICG) dose as a single dose-patient arm.\n\nIn the first time frame (intraoperative arms), the dose of, respectively 0.125 mg\u002Fkg and 0.25 mg\u002Fkg of ICG will be administered at induction anesthesia (at least 20 minutes before the BCS) in two subgroups.\n\nIn the second time frame, (preoperative arms), the dose of, respectively, 0.5 mg\u002Fkg, 1 mg\u002Fkg, and 2 mg\u002Fkg of ICG will be administered 24 h before surgery in 3 subgroups.",[85],"Breast Cancer",[87,88,89],"Breast cancer","Conservative surgery","Indocyanine Green","2025-02-25",{"date":92,"type":93},"2025-02-26","ACTUAL",{"date":95,"type":93},"2024-02-12",{"date":97,"type":79},"2026-01-01",{"name":5,"class":6},1]