[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552583":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":49,"collaborators":31,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":31,"enrollmentInfo":61,"targetDuration":31,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":31,"overallStatus":71,"whyStopped":31,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Identification of positive margins with PET\u002FCT specimen imager","EXPERIMENTAL","Identification of all positive margins of the invasive component during BCS using PET\u002FCT specimen imager",[13],"Device: AURA 10 PET\u002FCT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","AURA 10 PET\u002FCT","The PET\u002FCT specimen imager (AURA 10 PET\u002FCT) is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard",[9],[21],"PET\u002FCT specimen imager (AURA 10 PET\u002FCT)",[23],{"name":24,"affiliation":5,"role":25},"Francesco Ceci","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Francesco Ceci, MD","CONTACT","+390257489315",null,"francesco.ceci@ieo.it",{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},"Francesco Mattana","francesco.mattana@ieo.it",[37],{"facility":5,"status":31,"city":38,"state":31,"zip":31,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Milan","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],9.18951,45.46427,{"lat":45,"lon":44},[48],{"name":24,"role":29,"phone":31,"phoneExt":31,"email":31},{"type":50,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100552583","intra-surgery-high-resolution-specimen-petct-imager-for-margin-assessment-in-early-stage-breast-cancer-100552583",false,"NCT06474975","Intra-SURGerY High-resolution Specimen PET\u002FCT Imager for Margin Assessment in Early-stage Breast Cancer","SURGYPET: Intra-SURGerY High-resolution Specimen PET\u002FCT Imager for Margin Assessment in Early-stage Breast Cancer as Compared to Gross Pathology: a Prospective Non-inferiority Analysis","SURGYPET","Inclusion Criteria:\n\n* females with an age over 18 years;\n* confirmed breast cancer with indication to undergo BCS (stage I-II with tumor ≤2.5 in greatest dimension);\n* vacuum-assisted core breast biopsy is allowed for non-invasive tumors only;\n* able to understand treatment protocol and informed consent form;\n* estimated by the investigator to be compliant for study participation.\n\nExclusion Criteria:\n\n* general or local contra-indication for BCS;\n* previous breast surgery;\n* inflammatory breast cancer;\n* radiotherapy of the ipsilateral breast;\n* vacuum-assisted core breast biopsy for all patients with invasive tumors (vacuum-assisted core breast biopsy is allowed for patients with non-invasive tumors as long as the residual tumor size on mammogram is at least 1.0 cm);\n* pregnancy or lactation;\n* participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year;\n* active bacterial, viral or fungal infection.","FEMALE","18 Years",{"count":62,"type":63},150,"ESTIMATED","INTERVENTIONAL",[66],"NA","This study is a diagnostic open-label, prospective, single-arm non-inferiority clinical trial.\n\nThe primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma (IDC) patients by high-resolution specimen Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) imaging.",[69,70],"Breast Cancer","Breast-conserving Surgery","NOT_YET_RECRUITING","2024-06-20",{"date":74,"type":75},"2024-06-26","ACTUAL",{"date":77,"type":63},"2024-07",{"date":79,"type":63},"2026-07",{"name":5,"class":6},1]