[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07686250":3,"trial-entities:NCT07686250":94,"trial-summary:NCT07686250":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":52,"locations":55,"central_contacts":84,"overall_officials":90,"references":92,"see_also_links":93},"NCT07686250","MCC-24070","Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery","Clinical Evaluation and Outcomes of Multi-signal SAVI Scout (Scout MD) Localized Breast Conserving Surgery","RECRUITING","2028-07","2026-07","2026-07-30","H. Lee Moffitt Cancer Center and Research Institute","OTHER",false,"The purpose of the study is to evaluate how precise the SAVI Scout MD is and how easy it is for surgeons to use during surgery. The SAVI Scout MD system uses tiny radar reflectors instead of wires, can be placed days or weeks before surgery, helps surgeons find the cancer more precisely and may lower the chance of needing a second surgery.",null,[18],"Breast Cancer",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE2",{"count":25,"type":26},37,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","SAVI Scout MD system","Implantable radar reflector system allowing placement of multiple uniquely identifiable localizers for intraoperative tumor localization.",[33],"SAVI Scout MD Localization",[35],{"measure":36,"description":37,"timeFrame":38},"Successful Operation Rate (SOR)","Proportion of patients achieving complete tumor resection with negative surgical margins (\"no tumor on ink\" or ≥2 mm for DCIS).","Up to 6 weeks.",[],"FEMALE","18 Years",{"inclusion":43,"exclusion":47,"raw_text":51},[44,45,46],"Adult females who are 18 years of age or older at time of signing informed consent will be eligible.","Must have ability to comprehend and the willingness to sign written informed consent for study participation.","Patients must have at least one sonographically, mammographically, or MRI identifiable in-breast malignancy and consent to undergo a surgical resection requiring bracketed localization (more than one localizing marker) at Moffitt Cancer Center. Mammographically or sonographically visible biopsy clips may be used as a localizing target.",[48,49,50],"Patients undergoing mastectomy for resection of the targeted lesion.","Planned excision of multiple separate sites in the ipsilateral breast.","Inability to undergo surgery at Moffitt Cancer Center.","Inclusion Criteria:\n\n* Adult females who are 18 years of age or older at time of signing informed consent will be eligible.\n* Must have ability to comprehend and the willingness to sign written informed consent for study participation.\n* Patients must have at least one sonographically, mammographically, or MRI identifiable in-breast malignancy and consent to undergo a surgical resection requiring bracketed localization (more than one localizing marker) at Moffitt Cancer Center. Mammographically or sonographically visible biopsy clips may be used as a localizing target.\n\nExclusion Criteria:\n\n* Patients undergoing mastectomy for resection of the targeted lesion.\n* Planned excision of multiple separate sites in the ipsilateral breast.\n* Inability to undergo surgery at Moffitt Cancer Center.",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"status":8,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":81},"Moffitt Cancer Center","Tampa","Florida","33612","United States",[63,66,69,71,73,75,77,79],{"name":64,"role":65},"Marie Lee, MD","PRINCIPAL_INVESTIGATOR",{"name":67,"role":68},"Brian Czerniecki, MD","SUB_INVESTIGATOR",{"name":70,"role":68},"David Detz, MD",{"name":72,"role":68},"Nazanin Khakpour, MD",{"name":74,"role":68},"John Kiluk, MD",{"name":76,"role":68},"Laura Kruper, MD",{"name":78,"role":68},"Christine Laronga, MD",{"name":80,"role":68},"Melissa Mallory, MD",{"lat":82,"lon":83},27.94752,-82.45843,[85],{"name":86,"role":87,"phone":88,"email":89},"Diane Tendoh","CONTACT","813-745-4979","Diane.Tendoh@moffitt.org",[91],{"name":64,"affiliation":57,"role":65},[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Breast Carcinoma",[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an interventional study involving 37 women. It is designed to evaluate a new device for breast cancer surgery.","completed","SAVI Scout MD for Localized Breast Surgery","This study is looking at a new device called SAVI Scout MD for women undergoing surgery for breast cancer. The SAVI Scout MD system uses tiny radar reflectors, instead of wires, to help surgeons find the cancer more precisely. These reflectors can be placed days or weeks before surgery. The goal is to see how accurate the SAVI Scout MD is and how easy it is for surgeons to use, which may lead to a lower chance of needing a second surgery. We are looking for adult women, 18 years or older, who have breast cancer that can be seen on imaging (sonogram, mammogram, or MRI) and are planning to have surgery. The main way we'll know if the study is successful is by measuring the successful operation rate up to 6 weeks after surgery. The current recruitment status is unclear.","Participants will be followed for up to 6 weeks after surgery to assess the successful operation rate.",141,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]