[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607208":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":44,"locations":49,"responsibleParty":115,"collaborators":31,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":31,"enrollmentInfo":127,"targetDuration":31,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":141,"whyStopped":31,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Istituto Oncologico Veneto IRCCS","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"IntraOperative Ultrasound (IOUS) HydroMark™","EXPERIMENTAL","It is an advanced localization technique for non-palpable breast lesions, leveraging real-time ultrasound guidance combined with an ultrasound-visible tissue marker (HydroMark™) to facilitate precise tumor resection during breast-conserving surgery (BCS).",[13],"Procedure: IOUS HydroMark™",{"label":15,"type":10,"description":16,"interventionNames":17},"Magnetic Sirius Pintuition Seed®","It is an advanced, wire-free localization system designed for precise surgical guidance in non-palpable breast lesions. This technology utilizes a small, permanent magnetic seed that can be implanted into the tumor days, weeks, or even months before surgery, offering greater flexibility compared to traditional wire localization.",[18],"Procedure: Magnetic Sirius Pintuition Seed®",{"label":20,"type":21,"description":22,"interventionNames":23},"Wire localization","ACTIVE_COMPARATOR","It is the most widely used preoperative technique for guiding the surgical removal of non-palpable breast lesions. This method involves the insertion of a thin hooked wire into the lesion under radiological guidance (ultrasound, mammography, or stereotactic guidance) on the day of surgery. The wire serves as a physical guide for the surgeon, ensuring precise excision of the target lesion.",[24],"Procedure: Wire localization (WL)",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","IOUS HydroMark™","IOUS HydroMarkTM allows marking the tissue during percutaneous breast biopsy. This is a sterile, single-use marker made of resorbable hydrogel, which expands upon contact with bodily fluids and is then gradually absorbed. The hydrogel is visible on ultrasound. Inside the hydrogel, there is a metallic spiral (titanium\u002Fsteel) that remains permanently visible in radiographic and MRI examinations even after the hydrogel has been fully absorbed.\n\nThe HydroMARK Breast Biopsy Site Marker is made of a resorbable hydrogel that expands with fluid and is then resorbed. The hydrogel material is visible under ultrasound. Embedded in the hydrogel is a coiled metallic wire that will be permanently visible under x-ray and MRI when the hydrogel is resorbed. The HydroMARK Biopsy Site Marker is a permanent implant and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in applicator devices designed.",[9],null,{"type":27,"name":15,"description":33,"armGroupLabels":34,"otherNames":31},"The Pintuition Localization System is intended as a magnetic soft tissue localization system.\n\nThe magnetic Pintuition Seed is indicated for preoperative percutaneous implantation into soft tissue (glandular, fibrous or fatty tissue of breast; lymph nodes in the axillary and inguinal region; subcutaneous tissue and skeletal muscle tissue) for temporary marking (\\\u003C180 days) of a tissue of interest (e.g. tumor or a suspected lesion) indicated for surgical removal. Using the Pintuition Detector as magnetic guidance or, alternatively, image guidance (ultrasound or x-ray), the Pintuition Seed can be intra-operatively localized and removed together with the tissue of interest.",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":31},"Wire localization (WL)","Single-use, repositionable needle for preoperative localization of breast nodules with a single hook, equipped with a depth limiter. Designed for the localization of non-palpable breast lesions in the preoperative phase. It includes a fixation clamp to stabilize the positioning of the wire.",[20],[40],{"name":41,"affiliation":42,"role":43},"Massimo Ferrucci, MD PhD","Veneto Institute of Oncology IRCCS","PRINCIPAL_INVESTIGATOR",[45],{"name":41,"role":46,"phone":47,"phoneExt":31,"email":48},"CONTACT","0498215588","massimo.ferrucci@iov.veneto.it",[50,67,77,90,103],{"facility":51,"status":31,"city":52,"state":53,"zip":31,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Azienda Ospedaliera San Giovanni Addolorata","Roma","RM","Italy","IT",{"type":57,"coordinates":58},"Point",[59,60],11.10642,44.99364,{"lat":60,"lon":59},[63],{"name":64,"role":46,"phone":65,"phoneExt":31,"email":66},"Lucio Fortunato, MD","0677056762","lfortunato@hsangiovanni.roma.it",{"facility":68,"status":31,"city":52,"state":53,"zip":31,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"type":57,"coordinates":70},[59,60],{"lat":60,"lon":59},[73],{"name":74,"role":46,"phone":75,"phoneExt":31,"email":76},"Gianluca Franceschini, MD","3201803270","Gianluca.franceschini@policlinicogemelli.it",{"facility":78,"status":31,"city":79,"state":31,"zip":31,"country":54,"countryCode":55,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"AOU Policlinico di Modena","Modena",{"type":57,"coordinates":81},[82,83],10.92539,44.64783,{"lat":83,"lon":82},[86],{"name":87,"role":46,"phone":88,"phoneExt":31,"email":89},"Enza Palma, MD","0594225766","palma.enza@aou.mo.it",{"facility":91,"status":31,"city":92,"state":31,"zip":31,"country":54,"countryCode":55,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"ASL2 Abruzzo, Ospedale \"Gaetano Bernabeo\", Ortona","Ortona",{"type":57,"coordinates":94},[95,96],14.40342,42.35087,{"lat":96,"lon":95},[99],{"name":100,"role":46,"phone":101,"phoneExt":31,"email":102},"Simona Grossi, MD","3427282169","sgrossi@unich.it",{"facility":5,"status":31,"city":104,"state":31,"zip":105,"country":54,"countryCode":55,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Padova","35128",{"type":57,"coordinates":107},[108,109],11.14261,44.38225,{"lat":109,"lon":108},[112,114],{"name":41,"role":46,"phone":47,"phoneExt":31,"email":113},"massimoferrucci@gmail.com",{"name":41,"role":43,"phone":31,"phoneExt":31,"email":31},{"type":116,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100607208","intraoperative-ultrasound-guided-vs-wire-guided-vs-magnetic-seed-guided-breast-conserving-surgery-for-non-palpable-tumors-100607208",false,"NCT07185568","IntraOperative UltraSound Guided vs Wire Guided vs Magnetic Seed Guided Breast-Conserving Surgery for Non-palpable Tumors","IntraOperative UltraSound Guided Versus Wire Guided Versus Magnetic Seed Guided Breast-conserving Surgery for Non-palpable Tumors.The MANOLA Study Multi-center, Randomized, Open-label Clinical Trial","MANOLA","Inclusion Criteria:\n\n* Patients with non-palpable breast cancer candidate for breast-conserving surgery;\n* Female patients;\n* Patients aged ≥ 18 years;\n* Patients with histologic diagnosis of cT1-T2 invasive BC or ductal carcinoma in situ;\n* Patients amenable for BCS after neoadjuvant chemotherapy;\n* Patients who are able to give informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or lactation;\n* Patients with locally advanced disease or metastatic disease;\n* Patients with palpable breast carcinoma;\n* Patients candidate for mastectomy;\n* Patients who are unable to give informed consent\n* Patients candidate for mastectomy.","FEMALE","18 Years",{"count":128,"type":129},1302,"ESTIMATED","INTERVENTIONAL",[132],"NA","This is a multi-center, randomized, open-label clinical trial that will enroll 1302 adult patients with non-palpable breast lesions. Participant eligible for the study will be randomized in a 1:1:1 ratio to one of the pre-surgery lesion localization: IOUS HydroMark™ (experimental arm A), magnetic Sirius Pintuition Seed® (experimental arm B) and the wire localization technique (control arm). The randomization will be stratified by lesion type (solid non-palpable (type B); non-solid non-palpable (e.g., microcalcification clusters, architectural distortive areas) (type C); post-NACT residual lesions (type D), and clinical center.",[135,136],"Breast Cancer","Breast-Conserving Surgery",[138,139,140],"IntraOperative UltraSound guided","Wire guided","Magnetic Seed guided","NOT_YET_RECRUITING","2026-06-22",{"date":144,"type":145},"2026-06-23","ACTUAL",{"date":147,"type":129},"2026-08-04",{"date":149,"type":129},"2027-12-31",{"name":5,"class":6},5]