[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625759":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":41,"responsibleParty":59,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Royal College of Surgeons, Ireland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard 2D Speciman Mammography (Control)","ACTIVE_COMPARATOR","Participants undergo intraoperative specimen imaging using standard two-dimensional (2D) specimen mammography performed in the radiology department following tumour excision. The operating surgeon reviews the images intraoperatively to assess margin adequacy and determines whether additional excision is required prior to wound closure. All other aspects of surgical care follow standard institutional practice.",[13],"Procedure: Standard 2D Specimen Mammography",{"label":15,"type":16,"description":17,"interventionNames":18},"3D Digital Breast Tomosynthesis (Mozart System Intervention)","EXPERIMENTAL","Participants undergo intraoperative specimen imaging using three-dimensional (3D) digital breast tomosynthesis with the Mozart 3D Specimen Radiography System, performed directly in the operating theatre. The operating surgeon reviews reconstructed tomosynthesis images in real time to assess margin adequacy and determine whether additional excision is required prior to wound closure. All other aspects of surgical care remain unchanged.",[19],"Device: Mozart 3D Specimen Radiography System",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Standard 2D Specimen Mammography","Two-dimensional specimen mammography performed intraoperatively in the radiology department to assess surgical margins following breast-conserving surgery. Images are reviewed by the operating surgeon to guide additional excision if indicated.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","Mozart 3D Specimen Radiography System","Intraoperative digital breast tomosynthesis imaging performed in theatre using the Mozart 3D Specimen Radiography System (Kubtec). The system generates reconstructed 3D images of the excised specimen to allow real-time assessment of surgical margins by the operating surgeon.",[15],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Prof Arnold Hill, MB, BCh, BAO, MCh, FRCSI","CONTACT","018093000","adkhill@rcsi.com",{"name":39,"role":35,"phone":26,"phoneExt":26,"email":40},"Aisling Hegarty, PhD","Aislinghegarty@rcsi.ie",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Beaumont RCSI Cancer Centre","RECRUITING","Beaumont","Dublin","D09V2N0","Ireland","IE",{"type":51,"coordinates":52},"Point",[53,54],-6.22713,53.38721,{"lat":54,"lon":53},[57],{"name":39,"role":35,"phone":58,"phoneExt":26,"email":40},"0035317977800",{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100625759","margin-optimisation-using-z-axis-assessment-with-real-time-tomosynthesis-mozart-study-100625759",false,"NCT07426809","Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study).","MOZART","Inclusion Criteria:\n\n* Female patients\n* Age ≥ 18 years\n* Diagnosis of primary invasive breast cancer or ductal carcinoma in situ (DCIS)\n* Planned breast-conserving surgery with curative intent\n* No clinical or radiological evidence of distant metastatic disease at time of recruitment\n* Able to provide written informed consent\n* Fluent in English (spoken and written)\n\nExclusion Criteria:\n\n* Evidence of metastatic (stage IV) breast cancer\n* Planned mastectomy instead of breast-conserving surgery\n* Prior ipsilateral breast cancer surgery for the current malignancy\n* Inability to provide informed consent\n* Participation in another interventional study that may affect surgical margin assessment",true,"FEMALE","18 Years",{"count":72,"type":73},314,"ESTIMATED","INTERVENTIONAL",[76],"NA","Breast-conserving surgery is commonly performed to remove early-stage breast cancer or ductal carcinoma in situ (DCIS). During surgery, the goal is to completely remove the tumour with a clear margin of normal tissue around it. If cancer cells are found at the edge of the removed tissue (a \"positive margin\"), patients may need a second operation (re-excision). Re-excision can delay further treatment, increase patient anxiety, and increase healthcare costs.\n\nTo help assess margins during surgery, surgeons use specimen imaging. Standard practice involves two-dimensional (2D) specimen mammography, usually performed in the radiology department. This requires temporary transfer of the specimen out of the operating theatre and provides limited depth information.\n\nThe MOZART study is evaluating whether three-dimensional (3D) digital breast tomosynthesis, performed in the operating theatre using the Mozart system, improves margin assessment compared to standard 2D specimen mammography.\n\nPatients undergoing breast-conserving surgery at Beaumont Hospital who agree to participate will be randomly assigned (like flipping a coin) to one of two groups:\n\nStandard 2D specimen mammography (current standard practice), or\n\n3D digital breast tomosynthesis performed in theatre.\n\nIn both groups, the operating surgeon will review the images during surgery and decide whether additional tissue needs to be removed. The final margin status will be determined by routine laboratory analysis after surgery.\n\nThe main goal of this study is to compare the rate of positive margins between the two imaging methods. Other outcomes include the need for additional surgery, operating time, and overall workflow efficiency.\n\nThe results of this study may help determine whether intraoperative 3D imaging improves surgical outcomes and reduces the need for re-excision in patients undergoing breast-conserving surgery.",[79],"Breast Cancer",[79,66],"2026-03-30",{"date":83,"type":84},"2026-04-03","ACTUAL",{"date":86,"type":84},"2025-12-18",{"date":88,"type":73},"2028-12-31",{"name":5,"class":6},1]