Nctid:
NCT06227338
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001943", "term"=>"Breast Neoplasms"}], "ancestors"=>[{"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000001941", "term"=>"Breast Diseases"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M5218", "name"=>"Breast Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter:\n\n* at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or\n* in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg)."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>250}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-12", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-09", "completionDateStruct"=>{"date"=>"2026-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-28", "studyFirstSubmitDate"=>"2023-09-21", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Accuracy of ICG-FI technique for the detection of positive (involved) surgical margins at the patient level", "timeFrame"=>"2 years", "description"=>"The sensitivity (Se), specificity (Sp), negative predictive value (NPV), false negative rate (FNR), FPR of the ICG-FI technique will be computed at the patient level"}], "secondaryOutcomes"=>[{"measure"=>"Comparison of ICG-FI technique accuracy at different doses and timing", "timeFrame"=>"2 years", "description"=>"The sensitivity (Se), specificity (Sp), negative predictive value (NPV), false negative rate (FNR), FPR of the ICG-FI technique will be computed"}, {"measure"=>"Characterization of the breast tumor fluorescence (tumor-to- background fluorescence ratio)", "timeFrame"=>"2 years", "description"=>"Characterization of the appearance and intensity of fluorescence at the level of tumor cells"}, {"measure"=>"Evaluation of fluorescence intensity of axillary lymph nodes", "timeFrame"=>"2 years", "description"=>"The distribution of fluorescence intensity will be calculated depending on the type of axillary lymph node (LN) : sentinel vs other and respectively metastatic LN vs healthy LN)"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Breast cancer", "Conservative surgery", "Indocyanine Green"], "conditions"=>["Breast Cancer"]}, "descriptionModule"=>{"briefSummary"=>"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/kg and 0.25 mg/kg 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/kg, 1 mg/kg, and 2 mg/kg of ICG will be administered 24 h before surgery in 3 subgroups.", "detailedDescription"=>"The majority of breast cancer (BC) patients are diagnosed with an early-stage disease and are good candidates for breast-conserving surgery (BCS). Achieving adequate margins of excision is the most important component of BCS. Currently intra-operative margin assessment (IOMA) techniques used for margins evaluation in BC, either histological or imagistic is not accurate enough to predict the margins status of breast resected tumours and to guide surgery.\n\nFluorescence imaging (FI) using indocyanine green (ICG), a non-specific fluorophore, has also been reported to be a new, promising, non-invasive and relatively low cost technology to improving the accuracy of tumor detection during surgery in different clinical cancers, such as those of the liver, colon, ovaries, head and neck, lungs and breast. Furthermore ICG-FI can provide a real-time guidance during surgery and could establish corrects margins resection by improving the visual delineation between normal and tumoral tissues.\n\nOnly two clinical experience of ICG-FI for evaluating surgical margins in BC was reported. The group of Keating reported the first one, in a pilot study of 12 patients, after ICG intravenous (IV) injection (5mg/kg) they found that there was residual fluorescence in the tumoral bed in 6 out of 12 patients, but none of these patients had positive margins at definitive pathology. Recently, the investigators have reported the utility of ICG-FI after intraoperative ICG IV injection of 0.25 mg/kg for intraoperative breast surgical margin assessment during BCS. In a study of 35 BC patients, the investigators observed that the sensitivity (Se), specificity (Sp), and negative predictive value (NPV), of ICG-FI to predict margin involvement on the breast operative specimens were 100%, 60% and 100% respectively. Several important technical points exist in the experimental and clinical use of ICG-FI. There is a great variability of the published data regarding the baseline characteristics of the ICG use, like dosage and timing of administration (perioperative vs delayed). Furthermore, the fluorescence imaging system is usually different.\n\nIn this study, the investigators would like to emphasize and to get more precision about the optimal ICG doses and timing, which could increase the diagnostic accuracy of intraoperative ICG-FI for resection margins assessment during BCS, after intravenously ICG administration."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "genderBased"=>true, "healthyVolunteers"=>false, "eligibilityCriteria"=>"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/or cT2, assessed clinically and/or 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/or cT4);\n2. in situ breast cancer disease;\n3. lobular invasive breast cancer (at histology);\n4. invasive breast cancer treated by neoadjuvant chemotherapy and/or 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/dL);\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."}, "identificationModule"=>{"nctId"=>"NCT06227338", "acronym"=>"BREASTIFLU-1", "briefTitle"=>"ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study", "organization"=>{"class"=>"OTHER", "fullName"=>"Jules Bordet Institute"}, "officialTitle"=>"ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study", "orgStudyIdInfo"=>{"id"=>"IJB-S2022-IFIBC01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"0.125 mg/kg", "description"=>"Patients who will be injected with 0.125 mg/kg Indocyanine green before their tumorectomy", "interventionNames"=>["Drug: Indocyanine green"]}, {"type"=>"EXPERIMENTAL", "label"=>"0.25 mg/kg", "description"=>"Patients who will be injected with 0.25 mg/kg Indocyanine green before their tumorectomy", "interventionNames"=>["Drug: Indocyanine green"]}, {"type"=>"EXPERIMENTAL", "label"=>"0.5 mg/kg", "description"=>"Patients who will be injected with 0.5 mg/kg Indocyanine green before their tumorectomy", "interventionNames"=>["Drug: Indocyanine green"]}, {"type"=>"EXPERIMENTAL", "label"=>"1 mg/kg", "description"=>"Patients who will be injected with 1 mg/kg Indocyanine green before their tumorectomy", "interventionNames"=>["Drug: Indocyanine green"]}, {"type"=>"EXPERIMENTAL", "label"=>"2 mg/kg", "description"=>"Patients who will be injected with 2 mg/kg Indocyanine green before their tumorectomy", "interventionNames"=>["Drug: Indocyanine green"]}], "interventions"=>[{"name"=>"Indocyanine green", "type"=>"DRUG", "description"=>"Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter:\n\n* at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or\n* in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg).", "armGroupLabels"=>["0.125 mg/kg", "0.25 mg/kg", "0.5 mg/kg", "1 mg/kg", "2 mg/kg"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"1070", "city"=>"Brussels", "status"=>"RECRUITING", "country"=>"Belgium", "contacts"=>[{"name"=>"Florin Pop, MD", "role"=>"CONTACT", "email"=>"catalin.florin.pop@hubruxelles.be", "phone"=>"+322541", "phoneExt"=>"3244"}, {"name"=>"Sophie Vankerckhove", "role"=>"CONTACT", "email"=>"sophie.vankerckhove@hubruxelles.be", "phone"=>"+322541", "phoneExt"=>"7341"}], "facility"=>"Jules Bordet Institute", "geoPoint"=>{"lat"=>50.85045, "lon"=>4.34878}}], "centralContacts"=>[{"name"=>"Florin Pop, MD", "role"=>"CONTACT", "email"=>"catalin.florin.pop@hubruxelles.be", "phone"=>"+322541", "phoneExt"=>"3244"}], "overallOfficials"=>[{"name"=>"Florin Pop, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Jules Bordet Institute"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Jules Bordet Institute", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
