[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-metastasis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100367735","alpha-radiation-emitters-device-dart-for-the-treatment-of-of-malignant-cutaneous-tumors-100367735",false,"NCT04068155","Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors","A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors","Inclusion Criteria:\n\n* Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:\n\n  * SCC\n  * BCC\n  * Lentigo maligna melanoma (Dubreuilh melanoma)\n  * Carcinosarcoma\n* Acceptable tumor locations include the following:\n\n  * Skin (facial, scalp, extremities, torso)\n  * Lips\n  * Eyelids\n* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.\n* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.\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* 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 with histology of one of the following:\n\n  * Keratoacanthoma\n  * Merkel cell carcinoma\n  * Sarcoma other than carcinosarcoma\n* Metastatic disease (according to the TNM staging system - M1 patients are excluded)\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":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"NA","A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors",[26,27,28],"Skin Cancer","Cutaneous Tumor","Cutaneous Metastasis",[30,31,26,32,33,34,35,36,37,38,39,40,41,42,43],"Squamous Cell Carcinoma","Basal Cell Carcinoma","Skin Metastasis","Superficial Sarcoma","Alpha Radiation","Cutaneous Lesion","Brachytherapy","Radiotherapy","Lentigo maligna melanoma","Carcinosarcom","scalp cancer","Lip cancer","Eyelid cancer","SCC","RECRUITING","2026-06-15",{"date":47,"type":48},"2026-06-16","ACTUAL",{"date":50,"type":48},"2022-04-01",{"date":52,"type":20},"2028-01",{"name":54,"class":55},"Alpha Tau Medical LTD.","INDUSTRY",{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":5},"100565835","phase-4-the-effect-of-reduced-bleomycin-in-electrochemotherapy-treatment-100565835","NCT06647342","The Effect of Reduced Bleomycin in Electrochemotherapy Treatment","Randomised Controlled Clinical Trial Investigating the Effect of Reduced Bleomycin in Elechtrochemotherapy Treatment on Patients With Cutaneous Malignancies (The BLESS Trial)","BLESS","Inclusion Criteria:\n\n1. Trial subject \\> 18 years.\n2. Trial subject must be able to understand the participant information.\n3. Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.\n4. Life expectancy \\> 3 months.\n5. Trial subject can undergo simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy, etc.) at any point during the study.\n6. Trial subject may have received ECT treatment previously if selected tumours have not received ECT or if a minimum of 3 months after ECT treatment have passed.\n7. Trial subject can undergo radiation therapy, provided that the treatment field does not involve the area intended to treat. If the trial subject has received radiation therapy in the area intended to treat, a minimum of 3 months should have passed.\n8. A creatinine level within normal upper limit. If creatinine is above normal upper limit the subject needs to have a creatinine clearance \\> 50 ml\u002Fmin.\n9. Both men and women who are sexually active must use safe contraception. This includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization.\n10. Signed informed consent.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment.\n2. Allergy or hypersensitivity to bleomycin.\n3. Acute lung infection.\n4. Severely impaired lung function or any lung condition the investigator deems severe.\n5. Any other caution, clinical disease or previous treatments that make the investigator deem the trial subject unfit.\n6. The cumulative bleomycin dose must not exceed the by the drug manufacturer recommended maximum dose.",{"count":65,"type":20},55,[67],"PHASE4","The objective of this trial is to determine if reducing the chemotherapy dose in electrochemotherapy is equally effective as using the standard dose for treating various types of skin tumors.\n\nElectrochemotherapy involves administrating chemotherapy intravenously, followed shortly by a brief electrical pulse to the tumor. This pulses temporarily increases the tumor cells permeability, allowing the chemotherapy to enter more effectively.\n\nParticipants will undergo a single session of electrochemotherapy with either half the standard chemotherapy dose or the full standard dose. The size of the cutaneous tumors will be measured before treatment and again three months after the treatment to compare their response in both groups. To monitor the tumors, as well as assess the adverse events and quality of life, participants must attend follow-up visits at two weeks, three months and twelve months. Additional visits may be scheduled at one, two, four and six months, if necessary, as determined by the clinician or the patient. Concentration of chemotherapy will be measured in blood samples and in samples from the treated tumor and normal skin.",[28,70,71,72],"Cutaneous Malignant Mixed Tumor","Bleomycin Adverse Reaction","Electrochemotherapy",[74,75,72,76,77],"Deescalating study","Bleomycin","Cutaneous malignancies","Cutaneous tumors","2025-01-22",{"date":80,"type":48},"2025-01-23",{"date":82,"type":48},"2024-10-29",{"date":84,"type":20},"2027-12-31",{"name":86,"class":87},"Julie Gehl","OTHER"]