[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529076":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":53,"collaborators":28,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":28,"enrollmentInfo":66,"targetDuration":28,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sentinel node detection with 0.1mL SPIO and Technetium99","OTHER","An intradermal injection of SPIO (MagTrace®), according to the pre-specified dose of 0.1mL, will be performed 7 days, up to the day of surgery. The injection should be in the skin over the tumour, or at the border of the areola. All patients will also receive technetium per routine.",[13,14],"Drug: Superparamagnetic Iron Oxide","Device: Technetium99",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Superparamagnetic Iron Oxide","Superparamagnetic iron oxide (SPIO) consists of an iron oxide nanoparticle core and a hydrophilic coating to make it biocompatible and colloidal stable in a suspension. In this study injected intradermally in an ultra-low dose",[9],[22],"Magtrace",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Technetium99","Technetium99 +\u002F- blue dye is injected per routine as a comparator and as back up.",[9],null,[30],{"name":31,"affiliation":32,"role":33},"Fredrik Wärnberg","Sahlgrenska University Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":28,"email":38},"CONTACT","+4631823931","fredrik.warnberg@vgregion.se",[40],{"facility":41,"status":42,"city":43,"state":28,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":28},"Sahlgrenska Iniversity Hospital","RECRUITING","Gothenburg","41345","Sweden","SE",{"type":48,"coordinates":49},"Point",[50,51],11.96679,57.70716,{"lat":51,"lon":50},{"type":33,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":32,"oldNameTitle":28,"oldOrganization":28},"Roger Olofsson Bagge","Professor","100529076","phase-2-sentinel-lymph-node-localisation-with-an-ultra-low-dose-of-magtrace-in-breast-cancer-patients-100529076",false,"NCT06169072","Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients","Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer","MagSnow2","Inclusion Criteria:\n\n* Planned for sentinel lymph node biopsy at (or after) breast surgery\n* Signed and dated written informed consent before the start of specific protocol procedures\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding\n* Iron overload disease\n* Known hypersensitivity to iron, dextran compounds or blue dye.\n* Inability to understand given information and give informed consent or undergo study procedures","ALL","18 Years",{"count":67,"type":68},220,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +\u002F- blue dye, and to evaluate MRI breast artefacts and skin staining over time.",[74,75],"Breast Cancer","Sentinel Lymph Node",[77,78],"Breast cancer","Sentinel Lymph Node Biopsy","2024-01-25",{"date":81,"type":82},"2024-01-26","ACTUAL",{"date":84,"type":82},"2023-01-01",{"date":86,"type":68},"2027-07-01",{"name":5,"class":6},1]