[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552583":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":48,"collaborators":31,"id":50,"slug":31,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":31,"enrollmentInfo":59,"targetDuration":31,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":31,"overallStatus":69,"whyStopped":31,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"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,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Milan","Italy",{"type":41,"coordinates":42},"Point",[43,44],9.18951,45.46427,{"lat":44,"lon":43},[47],{"name":24,"role":29,"phone":31,"phoneExt":31,"email":31},{"type":49,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","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":60,"type":61},150,"ESTIMATED","INTERVENTIONAL",[64],"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.",[67,68],"Breast Cancer","Breast-conserving Surgery","NOT_YET_RECRUITING","2024-06-20",{"date":72,"type":73},"2024-06-26","ACTUAL",{"date":75,"type":61},"2024-07",{"date":77,"type":61},"2026-07",{"name":5,"class":6},1]