[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438806":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":18,"responsibleParty":37,"collaborators":7,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":7,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":7,"enrollmentInfo":48,"targetDuration":51,"studyType":52,"phases":7,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Albert Einstein College of Medicine","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Jana Fox, MD","Montefiore Medical Center","PRINCIPAL_INVESTIGATOR",[14],{"name":10,"role":15,"phone":16,"phoneExt":7,"email":17},"CONTACT","718-920-4140","jfox@montefiore.org",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Montefiore Medical Center - Moses Campus","RECRUITING","The Bronx","New York","10467-2490","United States","US",{"type":28,"coordinates":29},"Point",[30,31],-73.86641,40.84985,{"lat":31,"lon":30},[34,36],{"name":35,"role":15,"phone":16,"phoneExt":7,"email":17},"Jana Fox",{"name":35,"role":12,"phone":7,"phoneExt":7,"email":7},{"type":38,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100438806","intra-operative-radiation-registry-100438806",false,"NCT04994067","Intra-Operative Radiation Registry","Intra-Operative Radiation Therapy (IORT) Using the IntraBeam® System - A Registry Protocol","Inclusion Criteria:\n\n* Female gender\n* Age ≥ 45\n* cT1-2N0, \\\u003C3.5cm invasive breast cancer, estrogen-receptor positive or DCIS of breast, Grade 1-2, mammographically detected, \\\u003C 2.5 cm, estrogen-receptor positive\n* Suitable for breast conserving surgery\n* No contraindication to radiation\n* Mammogram within 6 months of planned procedure\n* Fitness for lumpectomy under general anesthesia\n* Planned to receive IORT\n\nExclusion criteria\n\n* Known axillary lymph node positive breast cancer (negative biopsy not required)\n* Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound, MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy.\n* Patients known to have BRCA 1\u002F2 (breast cancer 1, breast cancer 2) gene\n* Patients undergoing neoadjuvant chemotherapy\n* Pregnancy","FEMALE","18 Years",{"count":49,"type":50},500,"ESTIMATED","5 Years","OBSERVATIONAL","This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable partial breast irradiation (PBI) per the latest American Society of Radiation Oncology (ASTRO) guidelines.",[55],"Breast Cancer",[57,58],"intraoperative radiation therapy","partial breast irradiation","2025-09-18",{"date":61,"type":62},"2025-09-23","ACTUAL",{"date":64,"type":62},"2018-08-09",{"date":66,"type":50},"2032-08",{"name":5,"class":6},1]