[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531616":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":49,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Alpha Tau Medical LTD.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DaRT Seeds","EXPERIMENTAL","Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds",[13],"Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Diffusing Alpha Radiation Emitters Therapy (DaRT)","An intratumoral insertion of radioactive sources \\[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Liron Dimnik","CONTACT","+972542688602","LironD@alphatau.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Aviya Hoida","+972547869466","aviyah@alphatau.com",[32],{"facility":33,"status":34,"city":35,"state":20,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hadassah Medical Center","RECRUITING","Jerusalem","9777605","Israel","IL",{"type":40,"coordinates":41},"Point",[42,43],35.21633,31.76904,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":20,"phoneExt":20,"email":48},"Tanir Michal Eloise, MD","tanir@hadassah.org.il",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100531616","a-study-of-diffusing-alpha-radiation-therapy-for-patients-with-breast-carcinoma-in-frail-or-elderly-patients-100531616",false,"NCT06202118","A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.","A Pilot Feasibility and Safety Trial of Intratumoral Diffusing Alpha-emitter Radiation Therapy (DaRT) for the Treatment of Newly Diagnosed or Recurrent Breast Carcinoma in Frail or Elderly Patients.","Inclusion Criteria:\n\n* Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.\n* Tumor size ≤ 4 centimeters in the longest diameter.\n* Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery\n* De-novo or recurrent lesions.\n* Single lesion per quadrant per subject.\n* Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.\n* Interstitial implant indication validated by multidisciplinary team.\n* ECOG Performance Status ≤3.\n* Life expectancy ≥12 months.\n* Women Age ≥65 or younger if unfit for standard of care.\n* Willing and have the ability to provide signed Informed Consent.\n* Blood tests values:\n\n  * Leucocytes ≥3000mm3,\n  * Absolute neutrophil count ≥1500mm3,\n  * Platelets ≥100,000 mm3,\n  * Total bilirubin ≤ 1.5xULN,\n  * AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.\n  * Creatinine ≤ 2.0xULN.\n  * INR or Prothrombin time ≤1.5xULN\n\nExclusion Criteria:\n\n* T4 category with skin involvement.\n* Ductal carcinoma in situ.\n* Inflammatory breast carcinoma.\n* Longest tumor diameter \\>4 cm.\n* Patients with prior radiation to the same area within the past 6 months.\n* Has a known additional malignancy that is progressing or requires active treatment.\n* Patients undergoing immunosuppressive and\u002For systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease\n* Subjects not willing to sign an informed consent.","ALL","65 Years","120 Years",{"count":62,"type":63},10,"ESTIMATED","INTERVENTIONAL",[66],"NA","A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.",[69,70,71],"Breast Cancer","Recurrent Breast Cancer","Breast Carcinoma",[73,74,75,76],"Alpha radiation","Breast cancer","Newly Diagnosed Breast Carcinoma","Breast carcinoma","2025-02-06",{"date":79,"type":80},"2025-02-07","ACTUAL",{"date":82,"type":80},"2024-02-19",{"date":84,"type":63},"2026-06",{"name":5,"class":6},1]