[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100354053":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"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: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)","An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Tomer Charas, MD","Radiotherapy unit at Rambam Health Care Campus, Israel","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Liron Dimnik","CONTACT","+972-2-373-7000","LironD@alphatau.com",[33],{"facility":34,"status":35,"city":36,"state":20,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RAMBAM Health Care Campus","RECRUITING","Haifa","3109601","Israel","IL",{"type":41,"coordinates":42},"Point",[43,44],34.99928,32.81303,{"lat":44,"lon":43},[47,50],{"name":23,"role":29,"phone":48,"phoneExt":20,"email":49},"+972-4-777-6505","t_charas@rmc.gov.il",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100354053","alpha-radiation-emitters-device-dart-for-the-treatment-of-cutaneous-mucosal-or-superficial-soft-tissue-neoplasia-100354053",false,"NCT03889899","Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.","A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia","Inclusion Criteria:\n\n* Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.\n* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.\n* Measurable disease according to RECIST v1.1.\n* Subjects over 18 years old.\n* Subjects' ECOG Performance Status Scale is \\\u003C 2.\n* Subjects' life expectancy is more than 6 months.\n* Platelet count ≥100,000\u002Fmm3.\n* International normalized ratio of prothrombin time ≤1.8.\n* Creatinine ≤1.9 mg\u002FdL.\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.\n* Subjects are willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* Subject has a tumor of Keratoacanthoma histology.\n* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Subjects not willing to sign an informed consent.\n* Women who are pregnant or breastfeeding.","ALL","18 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"NA","A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia",[70,71,72],"Skin Cancer","Mucosal Neoplasm of Oral Cavity","Soft Tissue Neoplasm",[74,75,70,76,77,78,79,80,81,82,83,84,85,86],"Squamous Cell Carcinoma","SCC","Skin metastasis","HNSCC","Carcinoma, Squamous","CMN","Basal cell carcinoma","Superficial sarcoma","Kaposi sarcoma","Alpha radiation","Cutaneous lesion","Tongue cancer","Lip cancer","2025-12-01",{"date":89,"type":90},"2025-12-02","ACTUAL",{"date":92,"type":90},"2020-10-21",{"date":94,"type":64},"2026-09",{"name":5,"class":6},1]