[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524104":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":26,"interventions":36,"overallOfficials":20,"centralContacts":44,"locations":54,"responsibleParty":75,"collaborators":78,"id":95,"slug":20,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":20,"studyType":108,"phases":20,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":57,"whyStopped":20,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Sentinel lymph node detection rate","per patient","Perioperatively",[14,17],{"measure":15,"description":16,"timeFrame":12},"Number of sentinel lymph nodes detected per tracer","per node",{"measure":18,"description":19,"timeFrame":12},"Concordance of nodes per tracer","Ratio",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":23,"maskingInfo":20},"OTHER","PROSPECTIVE","This is an interventional single arm study. The aim is to see if sentinel lymph nodes marked with a magnetic tracer injected before preoperative chemotherapy can be detected at surgery three to six moths later. The investigators also want to see if they can find the same nodes with a tracer injected before chemotherapy as with a tracer injected after chemotherapy. The hypothesis is that the chemotherapy might affect the lymph drainage and the nodes marked before the chemotherapy are the true sentinel lymph nodes.\n\nFurthermore, in patients with known lymph node metastases before chemotherapy one metastasis is marked with a magnetic clip before the chemotherapy. This is a well known method but it has not been done in combination with the magnetic tracer. We will show that this is feasible.\n\nAll patients included in the study will receive their treatments according to the current standard national guidelines as both the magnetic tracer and the routinely used radioactive tracer are used in parallel. The magnetic clip is also used at several sites in Sweden today.","All patients planned for preoperative chemotherapy before breast surgery.",[27,32],{"label":28,"type":20,"description":29,"interventionNames":30},"Node negative","Clinically node negative before neoadjuvant chemotherapy",[31],"Device: Magtrace",{"label":33,"type":20,"description":34,"interventionNames":35},"Node positive","Clinically node positive before neoadjuvant chemotherapy",[31],[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DEVICE","Magtrace","Sentinel lymph node tracer and metastatic lymph node clip",[28,33],[43],"Magseed",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":20,"email":49},"Fredrik AM Warnberg, prof","CONTACT","+46706146251","fredrik.warnberg@vgregion.se",{"name":51,"role":47,"phone":52,"phoneExt":20,"email":53},"Kian AM Chin, MD","+46702316011","kian.chin@vgregion.se",[55],{"facility":56,"status":57,"city":58,"state":20,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Sahlgrenska University Hospital","RECRUITING","Gothenburg","413 45","Sweden","SE",{"type":63,"coordinates":64},"Point",[65,66],11.96679,57.70716,{"lat":66,"lon":65},[69,73],{"name":70,"role":47,"phone":71,"phoneExt":20,"email":72},"Roger Olofsson Bagge, Dr","+46 31 3428207","roger.olofsson.bagge@gu.se",{"name":70,"role":74,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":74,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":56,"oldNameTitle":20,"oldOrganization":20},"Roger Olofsson Bagge","professor",[79,81,83,85,87,89,91,93],{"name":80,"class":22},"Uppsala University",{"name":82,"class":22},"Region Västmanland",{"name":84,"class":22},"University Hospital, Linkoeping",{"name":86,"class":22},"Baylor College of Medicine",{"name":88,"class":22},"The University of Hong Kong-Shenzhen Hospital",{"name":90,"class":22},"Royal Marsden NHS Foundation Trust",{"name":92,"class":22},"University of Athens",{"name":94,"class":22},"University College Dublin","100524104",false,"NCT06104371","Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy","Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using Magtrace, (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients. SentiNeo 2.0","SentiNeo2","Inclusion criteria:\n\n* Patients 18 years of age or older.\n* Patients with breast cancer planned to undergo NACT with\n\n  * planned sentinel lymph node dissection (SLND), or\n  * targeted axillary lymph node dissection (TAD), in conjunction with the\n* breast surgery after NACT.\n\nExclusion Criteria:\n\n* Intolerance \u002F hypersensitivity to iron or dextran compounds or SPIO.\n* Patients who are required to undergo MRI to evaluate tumour response.\n* Pregnancy or breast feedin.g\n* Patients with an iron overload disease.\n* Patient deprived of liberty or under guardianship.\n* Inability to understand given information and give informed consent or undergo study procedure","ALL","18 Years","85 Years",{"count":106,"type":107},459,"ESTIMATED","OBSERVATIONAL","Magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. Also, magnetic tracer in combination with magnetic clip for index node identification.",[111],"Breast Cancer",[113,114],"sentinel lymph node detection","neoadjuvant chemotherapy","2026-02-19",{"date":117,"type":118},"2026-02-23","ACTUAL",{"date":120,"type":118},"2025-09-01",{"date":122,"type":107},"2028-12-31",{"name":5,"class":6},1]