[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alpha Tau Medical LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":446},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,45,74,96,120,145,164,183,206,226,248,279,308,332,357,376,403,424],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100574136","alpha-radiation-emitters-device-dart-for-the-treatment-of-locally-advanced-pancreatic-cancer-100574136",false,"NCT06755359","Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer","A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven locally advanced pancreatic adenocarcinoma\n* Target lesion is technically amenable for Alpha DaRT sources implantation.\n* Measurable lesion per RECIST (version 1.1) criteria\n* Stable disease or tumor response per RECIST (version 1.1) criteria compared to before initiation of mFOLFIRINOX\n* Lesion size ≤ 5 cm in the longest diameter\n* Interstitial radiation indication validated by a multidisciplinary team which includes an oncologist, a radiation oncologist, radiologist, gastroenterologist and a surgeon specialized in pancreatic oncology in the case that a surgical emergency occurs during the procedure\n* Patients have received 8 - 12 cycles of mFOLFIRINOX\n* ECOG Performance Status Scale 0 - 1\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n* Platelet count ≥60,000\u002Fµl\n* Creatinine ≤1.9 mg\u002FdL\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Age ≥18 years old\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\n\nExclusion Criteria:\n\n* Concomitant immunotherapy within the past 4 weeks.\n* Patients with metastatic disease\n* Borderline unresectable pancreatic cancer, and\u002For cases fit for surgical exploration unless patient refuses surgery.\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\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* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.","ALL","18 Years","120 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .",[27,28],"Pancreatic Cancer","Locally Advanced Pancreatic Cancer",[30,31],"Alpha radiation","pancreatic cancer","RECRUITING","2026-06-21",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2026-03-01",{"date":40,"type":21},"2027-06",{"name":42,"class":43},"Alpha Tau Medical LTD.","INDUSTRY",12,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100586048","alpha-radiation-emitters-device-dart-for-the-treatment-of-recurrent-glioblastoma-100586048","NCT06910306","Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma","A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma","Inclusion Criteria:\n\n* Males and females ≥ 18 and ≤ 85 years of age\n* Patients must have histologically confirmed diagnosis of WHO grade IV glioblastoma (including variants such as gliosarcoma, giant cell glioblastoma).\n* Single, gadolinium-enhancing tumor recurrence ≤ 3cm in maximum diameter\n* Patient not amenable for surgical resection due to any of the following but not limited reasons: patient refusal, medically ineligible, surgically too high risk due to tumor location in a deep and\u002For eloquent location.\n* Prior history of central nervous system (CNS) radiation (standard dose) with 50.4-60 Gy delivered in 1.8 Gy-2.0 Gy fractions with concurrent temozolomide (if the patient has received a non-standard fractionation or radiation dose, such as 40 Gy in 15 fractions.\n* Patients must have a time interval ≥4 months between completion of prior radiation and trial registration and have tumor progression per RANO criteria\n* Patients must have a measurable disease per RANO criteria\n* Estimated life expectancy is more than 6 months\n* Target lesion amenable for coverage by the DaRT sources\n* Patient must either have had recent subtotal surgery\u002Fbiopsy following tumor recurrence (at least 6 weeks from trial registration) or must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced MRI scan within 21 days prior to trial registration. If surgery was performed, must have a post-operative MRI scan within 21 days prior to trial registration.\n* Patients have recovered from prior therapy side effects and must be at least 4 weeks post administration of chemotherapies or investigational agents with the exception of nitrosureas (such as Carmustine, Fotemustine, Lomustine) which requires 42 days of washout.\n* Karnofsky performance score (KPS) of at least 60 documented within 14 days prior to trial registration\n* Patients must have adequate biological parameters as demonstrated by the following blood counts at initial screening obtained ≤ 14 days prior to starting treatment Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL Platelet count ≥ 100,000\u002Fmm3 (80 × 109\u002FL) Hemoglobin (Hgb) ≥ 9 g\u002FdL.\n* Patients must have the following blood chemistry levels at initial screening obtained ≤ 14 days prior to starting treatment AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN) Total bilirubin ≤ 1.5 × ULN\n* Effective contraception must be used by both male and female patients while on the study and for up to 3 months following treatment\n* Patient must have been informed about the nature of the study, and must have agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities\n\nExclusion Criteria:\n\n* Medical contraindication to MRI (cardiac devices are allowed if MRI compatible)\n* More than 3 relapses per RANO criteria\n* Acquired and or genetic clinical bleeding tendency\n* Suspicious of infratentorial or leptomeningeal or intraventricular disease\n* Concomitant chemotherapy or any other systemic therapy not allowed in the protocol\n* Recent or current (within 6 weeks) therapy with VEF or a VEGFR inhibitor\n* Immunocompromised state due to either transplant or AIDS\n* Prior allergic reaction to the study drugs\n* History of hypertensive crisis or hypertensive encephalopathy\n* Uncontrolled hypertension (defined as either \\>150 mm\u002FHg for systolic and \\>90mm\u002FHg for diastolic)\n* History of a non-healing wound, ulcer, gastrointestinal bleed (\\> grade 3), traumatic injury, or bone fracture within 90 days prior to registration 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* Pregnancy or lactation\n* Collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis","85 Years",{"count":54,"type":21},10,[24],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma",[58,59],"Recurrent Glioblastoma","Recurrent Gliomas",[58,61,62,63,64],"Brachytherapy","GBM","Alpha DaRT sources","Intratumoral Diffusing Alpha Emitters","2026-06-15",{"date":67,"type":36},"2026-06-16",{"date":69,"type":36},"2025-10-01",{"date":71,"type":21},"2026-12-01",{"name":42,"class":43},3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100569762","alpha-radiation-emitters-dart-with-chemotherapy-for-the-treatment-of-locally-advanced-and-metastatic-pancreatic-cancer-100569762","NCT06698458","Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer","A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and\u002For cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).\n* Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion\n* Target lesion is technically amenable for Alpha DaRT sources implantation.\n* Measurable lesion per RECIST (version 1.1) criteria\n* Lesion size ≤ 5 cm in the longest diameter\n* Interstitial radiation indication validated by a multidisciplinary team.\n* ECOG Performance Status Scale 0 -2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fμl, granulocyte ≥ 1500\u002Fμl\n* Platelet count ≥60,000\u002Fμl\n* Creatinine ≤1.9 mg\u002FdL\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Age ≥18 years old\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\n\nExclusion Criteria:\n\n* For Cohort 1 only: Borderline unresectable pancreatic cancer, and\u002For fit for surgical exploration unless patient refuses surgery.\n* For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment.\n\nExceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.\n\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\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* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after DaRT insertion\n* Patients who are at high risk of complications from radiation due to genetic conditions\u002Fmutations, inflammatory bowel disease, or connective tissue disease.",{"count":20,"type":21},[24],"This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to:\n\n* Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival.\n* Assess pain control\n* Assess rate of surgical resection in Cohort 1.",[27,85,86],"Pancreatic Adenocarcinoma","Metastatic Pancreatic Cancer",[30,31,85,88],"Unresectable Pancreatic Cancer",{"date":67,"type":36},{"date":91,"type":36},"2025-06-17",{"date":93,"type":21},"2026-12",{"name":42,"class":43},15,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":118,"locationsCount":119},"100563397","alpha-radiation-emitters-device-dart-for-the-treatment-of-cutaneous-scc-for-immunocompromised-patients-100563397","NCT06615635","Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous SCC for Immunocompromised Patients","A Pivotal, Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of Intratumoral Alpha DaRT224 for the Treatment of Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma","DaRT","Inclusion Criteria:\n\n* 1\\. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.\n\n  4\\. Patient able and willing to undergo multiple CT scans 5. Tumor size ≤7 cm, at the longest diameter. 6. Single lesion per subject. 7. Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds. Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye) as decided by treating physician and sponsor.\n\n  8\\. Interstitial implant indication validated by multidisciplinary team. 9. ECOG Performance Status ≤2. 10. Life expectancy ≥12 months. 11. Subjects male\u002F female ≥18. 12. Willing and have the ability to provide signed Informed Consent. 13. Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 1 year after the DaRT insertion visit.\n\n  14\\. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.\n\n  15\\. Blood tests values:\n  * Platelets ≥100,000 mm3,\n  * Total bilirubin ≤ 1.5xULN,\n  * AST ≤2.5xULN,\n  * SGOT ≤2.5xULN,\n  * SGPT ≤2.5xULN,\n  * Alkaline Phosphatase ≤2.5xULN.\n  * Creatinine Clearance ≥30 ml\u002Fmin.\n  * INR or Prothrombin time ≤1.5xULN.\n\nExclusion Criteria:\n\n* 1\\. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).\n\n  2\\. T4 disease 3. extensive PNI 4. Previously untreated cutaneous SCC 5. Mucosal SCC. 6. Inability to fully cover the entire volume with DaRT seeds 7. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs 8. Inability or unwillingness to undergo multiple CT scans 9. Patients receiving any of the following within 4 weeks of enrollment:\n  1. Antineoplastic systemic chemotherapy or biological therapy\n  2. Immunotherapy\n  3. Investigational agents other than the study intervention\n  4. Radiation therapy\n  5. Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.\n\n     10\\. Longest tumor diameter \\>7 cm. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to any component of treatment. 13. Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, history of myocardial infarction in the last 12 months.\n\n     14\\. Any medical or Psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to tolerate treatment and to adhere to the clinical trial protocol.\n\n     15\\. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and\u002For interpretation of treatment safety or effectiveness.\n\n     16\\. High probability of protocol non-compliance (in opinion of investigator). 17. 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\n     18\\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n\n     19\\. Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 1 year after the DaRT insertion visit.\n\n     20\\. Breastfeeding or pregnant women 21. Tattoos scars, body jewelry (e.g., nose rings) or other identifying marks which cannot be adequately hidden on digital photos or other identifying marks which cannot be adequately hidden on digital photos",{"count":105,"type":21},28,[24],"This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to:\n\n1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion.\n2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.\n3. Assess Local control up to 12 months after DaRT insertion.",[109,110,111,112,113,61],"Squamous Cell Carcinoma","Alpha Radiation","Immunocompromised","Carcinoma, Squamous","Skin Cancer",{"date":67,"type":36},{"date":116,"type":36},"2026-01-01",{"date":93,"type":21},{"name":42,"class":43},11,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":127,"minAge":17,"maxAge":18,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":143,"locationsCount":144},"100531626","alpha-radiation-emitters-device-dart-for-the-treatment-of-non-metastatic-locally-recurrent-prostate-cancer-100531626","NCT06202248","Alpha Radiation Emitters Device (DaRT) for the Treatment of Non-Metastatic Locally Recurrent Prostate Cancer.","A Feasibility and Safety Study of Focal Interstitial Radiotherapy Using Diffusing Alpha Emitters Radiation Therapy (DaRT) Seeds in Men With Non-metastatic Locally Recurrent Prostate Cancer.","Inclusion Criteria:\n\n* Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging findings within 6 months prior to consenting\n* Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 or by multiparametric MRI according RECIST v1.1\n* Patient being considered for focal salvage brachytherapy\n* Lesion size ≤ 3 cm in the longest diameter\n* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds\n* Pre-salvage PSA level (rPSA) below \\\u003C10 ng\u002Fml\n* Age ≥ 18 years old\n* ECOG Performance Status Scale ≤ 2\n* Subjects' life expectancy is more than 6 months\n* Negative metastatic workup on at least standard imaging (CT CAP and bone scan). Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate\u002Fwhole body, PSMA PET, F18 PET or Axumin PET within 3 months before visit 0\n* Platelet count ≥100,000\u002Fmm3\n* Subjects are willing and able to sign an informed consent form.\n\nExclusion Criteria:\n\n* N1 or M1 disease\n* Prior TURP or prostate surgery\n* Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI)\n* Inability to undergo general or spinal anesthesia\n* Prior androgen deprivation therapy or systemic chemotherapy for prostate cancer within 3 months before visit 0.\n* Previous diagnosis of other malignancy \\\u003C 3 years of enrollment (excluding non-melanomatous skin cancer)\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* 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.)","MALE",{"count":54,"type":21},[24],"This is a multi-center clinical study enrolling up to 10 participants. The purpose of this study is to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of locally recurrent prostate cancer. Secondary objectives are to 1. To evaluate feasibility of interstitial radiotherapy using DaRT seeds.\n\nFeasibility will be determined according to the rate of successful placement of DaRT seeds via imaging \\[Timeframe: immediately following the insertion procedure 2. To assess the impact of DaRT seeds on patient reported quality of life.",[132,133],"Non-metastatic Prostate Cancer","Locally Recurrent Prostate Cancer",[135,136,137,138],"recurrent prostate cancer.","Alpha emitting radiation","Alpha DaRT","Prostate cancer",{"date":67,"type":36},{"date":141,"type":36},"2024-03-12",{"date":40,"type":21},{"name":42,"class":43},1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":156,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":144},"100518161","alpha-radiation-emitters-for-the-treatment-of-pancreatic-cancer-for-the-treatment-of-locally-advanced-pancreatic-cancer-100518161","NCT06026943","Alpha Radiation Emitters for the Treatment of Pancreatic Cancer for the Treatment of Locally Advanced Pancreatic Cancer","A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven NCCN locally advanced PC\n* Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery.\n* DaRT indication validated by a multidisciplinary team.\n* Measurable lesion per RECIST (version 1.1) criteria\n* TC at Verona's center (not been over a month)\n* Lesion size ≤ 5 cm in the longest diameter\n* Age ≥18 years old\n* ECOG Performance Status Scale ≤ 2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fμl, granulocyte ≥ 1500\u002Fμl\n* Platelet count ≥60,000\u002Fμl\n* Calculated or measured creatinine clearance ≥ 30cc\u002Fmin. Calculated or measured creatinine clearance can be ≥ 40cc\u002Fmin given stability of creatinine levels over the past three weeks (at least 1 test per week).\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n\nExclusion Criteria:\n\n* Concomitant chemotherapy or immunotherapy within the past 4 weeks\n* Prior radiation therapy to the pancreas\n* CA 19-9 \\> 1000 Units\u002Fml\n* Fit for surgical exploration unless the patient refuses surgery\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\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* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.",{"count":95,"type":21},[24],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer",[27,88,85],[31,88,85,30,157],"Pancreas Cancer",{"date":67,"type":36},{"date":160,"type":36},"2026-05-06",{"date":162,"type":21},"2028-01",{"name":42,"class":43},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":144},"100502979","alpha-radiation-emitters-device-dart-for-the-treatment-of-liver-metastases-100502979","NCT05829291","Alpha Radiation Emitters Device (DaRT) for the Treatment of Liver Metastases","A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Liver Metastases","Inclusion Criteria:\n\n1. Referred for a two staged hepatectomy following a multidisciplinary team discussion, to resect liver metastases of colorectal cancer\n2. Targetable lesion(s) must be technically amenable for complete coverage (including margins) by the Alpha DaRT Seeds \u002F Target(s) must be reachable for implantation\n3. Liver lesions are visible and measurable by CT according to RECIST v 1.1\n4. Age ≥ 18 years old\n5. ECOG Performance Status Scale ≤ 2\n6. Subjects' life expectancy is at least 12 weeks\n7. The following laboratory parameters\n\n   * WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n   * Hemoglobin \\> 85 g\u002FL\n   * Total bilirubin \\\u003C 51.3 umol\u002FL\n   * Platelet count \\>75 X 109 \u002FL or \\> 50% Prothrombin activity\n   * Amylase and lipase \\\u003C 1.5 X the upper limit of normal\n   * AST and ALT ≤ 5 X ULN\n   * Prothrombin time (PT) international normalized ratio (INR) \\\u003C 2.3 or PT \\\u003C 6 seconds above control. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists\n8. Subjects are willing and able to sign an informed consent form\n9. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test within seven days before the Ra-224 implantation\n10. Subjects must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy\n\nExclusion Criteria:\n\n1. Concurrent cancer that is distinct in primary site or histology from colorectal cancer. Except cervical carcinoma in situ, prostate cancer with good prognosis, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \\& T1). Any cancer curatively treated 3 years prior to entry is permitted.\n2. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids\n3. Contraindication to angiography:\n\n   * Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agent\n   * Severe peripheral vascular disease precluding catheterization\n   * History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically\n4. Known hypersensitivity to any of the components of the treatment.\n5. Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n6. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.\n7. Brain metastases\n8. Active clinically serious infections\n9. Major surgery within 4 weeks of start of the study therapy\n10. Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n11. Any condition that is unstable or which could jeopardize the safety of the patient and his\u002Fher compliance in the study\n12. High probability of protocol non-compliance (in opinion of investigator)\n13. Pregnant or breastfeeding women\n14. 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\n    \\-",{"count":54,"type":21},[24],"This is a single center study enrolling up to 10 patients. The primary objective is to Evaluate the feasibility and safety of the DaRT for the treatment of Liver Metastases. The secondary objective is to evaluate the pathological response of liver metastases according to the Modified tumor regression grade\\[1\\] and to evaluate the radiological response of liver metastases using the RECIST criteria.",[175],"Liver Metastases",[30,136,175,61],{"date":67,"type":36},{"date":179,"type":36},"2023-10-01",{"date":181,"type":21},"2027-07",{"name":42,"class":43},{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":144},"100499307","alpha-radiation-emitters-device-dart-for-target-treatments-of-malignant-tumors-100499307","NCT05781555","Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors","A Prospective, Open Label, One Arm Study for a Compassionate Use of Diffusing Alpha Radiation Therapy","Inclusion Criteria:\n\n* Subjects with any malignancy\n* Subjects with a tumor size ≤ 7 centimeters in the longest diameter\n* Subjects over 18 years old\n* Subjects' life expectancy is more than 6 months\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after treatment.\n* Subjects\u002FSurrogate decision maker are willing to sign an informed consent form\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the components of the treatment.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.\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* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Subjects\u002FSurrogate decision maker not willing to sign an informed consent.\n* Women who are pregnant or breastfeeding.",{"count":191,"type":21},100,[24],"This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.",[195],"Malignant Tumor",[197,195,198,61,136,199],"Tumor","Cancer","Compassionate treatment",{"date":67,"type":36},{"date":202,"type":36},"2023-03-22",{"date":204,"type":21},"2027-04",{"name":42,"class":43},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":154,"conditions":215,"keywords":216,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},"100489793","alpha-radiation-emitters-device-for-the-treatment-of-advanced-pancreatic-cancer-feasibility-and-safety-100489793","NCT05657743","Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer (Feasibility and Safety)","A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer","Inclusion Criteria\n\n* Histologically and\u002For cytologically proven locally advanced or metastatic pancreatic adenocarcinoma\n* Patients must have i) received at least one line of chemotherapy OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery or the patient does not wish to go through surgery\n* Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician\n* Interstitial radiation indication validated by a multidisciplinary team\n* Measurable lesion per RECIST (version 1.1) criteria\n* Lesion size ≤ 5 cm in the longest diameter\n* Age ≥18 years old\n* ECOG Performance Status Scale ≤ 2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n* Platelet count ≥60,000\u002Fµl\n* Calculated or measured creatinine clearance ≥ 60cc\u002Fmin. Calculated or measured creatinine clearance can be≥ 40cc\u002Fmin given stability of creatinine levels over the past three weeks (at least 1 test per week).\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n\nExclusion Criteria:\n\n* Concomitant chemotherapy or immunotherapy within the past 4 weeks\n* Brain metastases\n* Borderline unresectable pancreatic cancer, and\u002For cases fit for surgical exploration unless patient refuses surgery\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\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* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.",{"count":95,"type":21},[24],[27,88,86,85],[31,88,86,85,217,30,218],"Pancreas Neoplasm","Pancreas Metastases",{"date":67,"type":36},{"date":221,"type":36},"2023-08-16",{"date":223,"type":21},"2027-11",{"name":42,"class":43},2,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":144},"100487885","alpha-radiation-emitters-device-dart-for-the-treatment-of-recurrent-lung-cancer-100487885","NCT05632913","Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Lung Cancer","A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Recurrent Lung Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven recurrent mediastinal tumors\n* Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician\n* Up to two treatable lesions\n* Interstitial radiation indication validated by a multidisciplinary team.\n* Measurable lesion per RECIST (version 1.1) criteria\n* Lesion size ≤ 3 cm in the longest diameter\n* Age ≥18 years old\n* ECOG Performance Status Scale ≤ 3\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n* Platelet count ≥60,000\u002Fµl\n* Calculated or measured creatinine clearance ≥ 60cc\u002Fmin. Calculated, or measured creatinine clearance can be≥ 40cc\u002Fmin given stability of creatinine levels over the past three weeks (at least 1 test per week).\n* AST and ALT ≤ 2.5 X ULN\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n\nExclusion Criteria:\n\n* Concomitant chemotherapy or immunotherapy\n* Brain metastases Connective tissue disease (scleroderma, lupus)\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\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* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.",{"count":54,"type":21},[24],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for treatment of recurrent Lung Cancer .",[237,238],"Recurrent Lung Cancer","Lung Cancer",[30,240,241],"Lung cancer","Recurrent lung cancer",{"date":67,"type":36},{"date":244,"type":36},"2023-07-01",{"date":246,"type":21},"2027-02",{"name":42,"class":43},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":144},"100403501","alpha-radiation-emitters-device-dart-for-the-treatment-of-cutaneous-mucosal-or-superficial-soft-tissue-neoplasia-100403501","NCT04534127","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. Confirmation obtained within 6 months of planned treatment.\n* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.\n* Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds\n* Brachytherapy indication validated by a multidisciplinary team\n* Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.\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* WBC ≥ 3500\u002Fμl, granulocyte ≥ 1500\u002Fμl\n* AST and ALT ≤ 2.5 X ULN\n* International normalized ratio of prothrombin time ≤1.8.\n* Creatinine ≤1.9 mg\u002FdL. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n* Subjects are willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* Subject has a tumor of Keratoacanthoma histology.\n* Known hypersensitivity to any of the components of the treatment.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids\n* Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT\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* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\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.",{"count":256,"type":21},56,[24],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia",[113,260,261],"Mucosal Neoplasm of Oral Cavity","Soft Tissue Neoplasm",[109,263,113,264,265,112,266,267,268,269,30,270,271,272,61],"SCC","Skin metastasis","HNSCC","CMN","Basal cell carcinoma","Superficial sarcoma","Kaposi sarcoma","Cutaneous lesion","Tongue cancer","Lip cancer",{"date":67,"type":36},{"date":275,"type":36},"2020-12-22",{"date":277,"type":21},"2027-07-01",{"name":42,"class":43},{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":22,"phases":288,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":225},"100367735","alpha-radiation-emitters-device-dart-for-the-treatment-of-of-malignant-cutaneous-tumors-100367735","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.",{"count":287,"type":21},80,[24],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors",[113,291,292],"Cutaneous Tumor","Cutaneous Metastasis",[109,294,113,295,296,110,297,61,298,299,300,301,272,302,263],"Basal Cell Carcinoma","Skin Metastasis","Superficial Sarcoma","Cutaneous Lesion","Radiotherapy","Lentigo maligna melanoma","Carcinosarcom","scalp cancer","Eyelid cancer",{"date":67,"type":36},{"date":305,"type":36},"2022-04-01",{"date":162,"type":21},{"name":42,"class":43},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":127,"minAge":315,"maxAge":18,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":322,"overallStatus":323,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100615314","alpha-radiation-emitters-device-dart-for-the-treatment-of-locally-recurrent-prostate-cancer-100615314","NCT07290998","Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Recurrent Prostate Cancer","A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Recurrent Prostate Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven prostate adenocarcinoma\n* Biochemical recurrence by the Phoenix definition (PSA nadir + 2 ng\u002FmL) and confirmed by a pre-treatment biopsy.\n* Patients eligible for focal salvage brachytherapy\n* Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum\n* Pre-salvage PSA level (rPSA) \\\u003C 10 ng\u002Fml\n* Target lesion is technically amenable for Alpha DaRT sources implantation.\n* Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 OR by multiparametric MRI according RECIST v1.1 (Patients who were classified as stage II according to MRI)\n* Lesion size ≤ 5 cm in the longest diameter\n* ECOG Performance Status Scale 0 - 2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n* Platelet count ≥60,000\u002Fµl\n* Creatinine ≤1.9 mg\u002FdL\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Age ≥ 40 years old\n* Subjects are willing and able to sign an informed consent form\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) for 3 months after DaRT insertion\n\nExclusion Criteria:\n\n* Concomitant immunotherapy within the past 4 weeks.\n* Patients with lymph node or metastatic disease\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Patients with prior surgery or low-dose-rate (LDR) brachytherapy as the primary treatment of their prostate cancer.\n* \\[For Stage 1 of the study only\\] Patients with prior high-dose-rate (HDR) brachytherapy or stereotactic body radiation therapy (SBRT) as the primary treatment of their prostate cancer.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation, and for 3 months after DaRT insertion\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).","40 Years",{"count":44,"type":21},[24],"This is a multi-center clinical study enrolling up to 12 participants . The primary objective of the study is to evaluate the safety of Alpha DaRT for the treatment of locally recurrent prostate cancer . The secondary objectives of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by biochemical and clinical evaluation of disease progression as well as overall survival",[320,321,133],"Prostate Cancer","Recurrent Prostate Cancer",[30,320,321],"NOT_YET_RECRUITING","2026-03-31",{"date":326,"type":36},"2026-04-06",{"date":328,"type":21},"2026-05",{"date":330,"type":21},"2029-05",{"name":42,"class":43},{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":356,"locationsCount":73},"100442877","alpha-radiation-emitters-device-dart-in-combination-with-check-point-inhibitor-for-the-treatment-of-recurrent-unresectable-or-mhnscc-100442877","NCT05047094","Alpha Radiation Emitters Device (DaRT) in Combination With Check Point Inhibitor for the Treatment of Recurrent Unresectable or mHNSCC","A Safety and Efficacy Study of Intratumoral Diffusing Alpha Radiation Emitters in Recurrent Unresectable or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Pathologically confirmed, metastatic, or recurrent unresectable squamous cell carcinoma of the head and neck.\n2. Ability to provide tissue sample, either from an archive or undergo another biopsy to provide a fresh sample\n3. Targetable lesion must be technically amenable for the DaRT seeds implantation\n4. Brachytherapy indication validated by a multidisciplinary team\n5. Targetable lesion according to RECIST v1.1\n6. Age ≥ 18 years old\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale ≤ 2\n8. Subjects' life expectancy is more than 6 months\n9. White Blood Count (WBC) ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n10. Platelet count ≥ 100,000\u002Fµl\n11. Hemoglobin ≥ 9 g\u002Fdl\n12. Calculated or measured creatinine clearance ≥ 60 cc\u002Fmin\n13. Aspartate Aminotransferase (AST) and Alanine Transaminase (ALT) ≤ 2.5 X Upper Limit of Normal (ULN) or ≤ 5 X ULN for subjects with liver metastases\n14. International normalized ratio (INR) \\\u003C1.4 for patients not on Warfarin\n15. Subjects are willing and able to sign an informed consent form\n16. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n\nExclusion Criteria:\n\n1. Previous treatment for metastatic disease (for recurrent unresectable disease, previous treatment is allowed given that 6 months had elapsed from completion of treatment for primary disease)\n2. Patients with brain metastases\n3. Combined Positive Scores (CPS) \\\u003C1\n4. Patients with known contraindications to radiotherapy\n5. Any prior therapy with anti-PD-L1 (Programmed death-ligand), anti-PD-L2, anti-CTLA-4 (Cytotoxic T lymphocyte antigen) antibody, etc.\n6. Any history of a sever hypersensitivity reaction to any monoclonal antibody.\n7. Known hypersensitivity to any of the components of the DaRT.\n8. Has a known history of active TB (Tuberculosis Bacillus )\n9. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n10. Any diagnosis of immunodeficiency or current immunosuppressive therapy including \\>10mg\u002Fday of prednisone within 14 days of enrollment is not permitted\n11. Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n12. Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n13. Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n14. Has a known history of Human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies).\n15. Has known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected)\n16. Pregnancy or lactation.\n17. Patients must agree to use adequate contraception (abstinence, barrier method of birth control, or any other medically acceptable form of contraception) prior to study entry, for the duration of study participation and for 6 months after last dose of Pembrolizumab.",{"count":340,"type":21},48,[24],"A unique combinational treatment for cancer employing intratumoral diffusing alpha radiation emitter device with check point inhibitor for recurrent unresectable or metastatic Head and Neck Squamous Cell Carcinoma",[344,113,345],"Head and Neck Squamous Cell Carcinoma","Metastatic Head-and-neck Squamous-cell Carcinoma",[109,263,113,264,265,112,347,30,61,348,349,350,351],"Recurrent disease","Pembrolizumab","Check Point Inhibitor","KEYTRUDA","Immunomodulators",{"date":326,"type":36},{"date":354,"type":36},"2021-11-02",{"date":40,"type":21},{"name":42,"class":43},{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":253,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":258,"conditions":366,"keywords":367,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":144},"100354053","alpha-radiation-emitters-device-dart-for-the-treatment-of-cutaneous-mucosal-or-superficial-soft-tissue-neoplasia-100354053","NCT03889899","Alpha Radiation Emitters Device (DaRT) for the Treatment of 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.",{"count":364,"type":21},30,[24],[113,260,261],[109,263,113,264,265,112,266,267,268,269,30,270,271,272],"2025-12-01",{"date":370,"type":36},"2025-12-02",{"date":372,"type":36},"2020-10-21",{"date":374,"type":21},"2026-09",{"name":42,"class":43},{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":16,"minAge":383,"maxAge":18,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":391,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":144},"100531616","a-study-of-diffusing-alpha-radiation-therapy-for-patients-with-breast-carcinoma-in-frail-or-elderly-patients-100531616","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.","65 Years",{"count":54,"type":21},[24],"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.",[388,389,390],"Breast Cancer","Recurrent Breast Cancer","Breast Carcinoma",[30,392,393,394],"Breast cancer","Newly Diagnosed Breast Carcinoma","Breast carcinoma","2025-02-06",{"date":397,"type":36},"2025-02-07",{"date":399,"type":36},"2024-02-19",{"date":401,"type":21},"2026-06",{"name":42,"class":43},{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":323,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":423,"locationsCount":144},"100444278","neoadjuvant-dart-for-locally-advanced-oral-cavity-scc-100444278","NCT05065346","Neoadjuvant DaRT for Locally Advanced Oral Cavity SCC","A Study to Evaluate the Efficacy of Neoadjuvant DaRT for Locally Advanced Oral Cavity Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the oral cavity (no involvement of the lips);\n2. T1-T2, N1-N2; T3 N0-2 with T3 \\\u003C5 cm, depth of infiltration \\\u003C15 mm, (AJCC version 8 oral cavity);\n3. Tumor must be potentially curable by conventional methods;\n4. Primary tumor must be amenable for complete coverage (including margins) by the DaRT seeds;\n5. Assessment by a Multi-Disciplinary Team (MDT) of the treatment naïve patient and suitable for DaRT based on diagnostic, contrast enhanced whole body PET-CT - and MRI at the discretion of the investigator - within 2 weeks prior to enrolment. MDT preferably composed of a head and neck\u002Fear, nose, and throat (ENT) surgeon, medical oncologist, radiologist, radiotherapist, and pathologist but at least a surgeon and a radiotherapist;\n6. Age 18 and older;\n7. Eastern Cooperative Oncology Group (ECOG)\u002F World Health Organization (WHO) Performance status 0-2;\n8. Adequate bone marrow function as demonstrated by neutrophils (ANC) ≥ 1,5 109 \u002FL, platelet count ≥ 100 109 \u002FL, leukocytes (WBC) ≥ 3.0 109 \u002FL;\n9. Hemoglobin ≥ 9.0 g\u002FdL\n10. Calculated creatinine clearance (CL) \\> 60 mL\u002Fmin by the Cockcroft-Gault formula;\n11. Coagulation parameter (as per institution's standard international normalized ratio (INR), PT or Quick PT) is within the normal ranges, or within the expected target range of their current dose for those patients receiving anticoagulant therapy.\n12. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 21 days prior to the DaRT insertion.\n\n    Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression or other reasons.\n13. Patients of childbearing \u002F reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last dose of treatment.\n\n    Note: A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:\n    * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n    * Intrauterine device (IUD)\n    * Intrauterine hormone-releasing system (IUS)\n    * Bilateral tubal occlusion\n    * Vasectomized partner\n    * Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)\n14. Female subjects who are breast-feeding should discontinue nursing prior to starting treatment and until 6 months after the last dose of study treatment;\n15. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up;\n16. Willing and able to provide tumor specimen and blood samples for translational research;\n17. Before patient registration\u002Frandomization, written informed consent must be given according to International Conference on Harmonization (ICH)\u002F Good Clinical Practice (GCP), and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n1. Floor-of-mouth primaries or extension onto the floor-of-mouth;\n2. Documented evidence of distant metastases (M1) based on a diagnostic, contrast-enhanced whole-body PET-CT scan ;\n3. Any previous anti-cancer therapy for HNSCC (surgery, chemo, radiotherapy or molecularly targeted therapy);\n4. History of another primary malignancy with the exception of:\n\n   * Malignancy treated with curative intent and with no known active disease ≥2 years before enrolment and of low potential risk for recurrence\n   * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   * Adequately treated carcinoma in situ without evidence of disease;\n5. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study;\n6. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before enrolment in the trial;\n7. Known contraindication to imaging tracer or nay product of contrast media, or MRI contraindications.",{"count":411,"type":21},79,[24],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device (DaRT) as a treatment prior to additional radiation or chemo therapy.",[109,344],[416,298,61,110],"Oral Cavity Squamous Cell Carcinoma","2024-05-16",{"date":419,"type":36},"2024-05-17",{"date":421,"type":21},"2025-03",{"date":401,"type":21},{"name":42,"class":43},{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":431,"minAge":17,"maxAge":18,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":438,"overallStatus":323,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":4},"100531633","alpha-radiation-emitters-device-for-the-treatment-of-primary-and-recurrent-squamous-cell-carcinoma-of-the-vulva-dart-100531633","NCT06202339","Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).","A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva","Inclusion Criteria:\n\n1. Histologically confirmed newly diagnosed or recurrent (local) vulva SCC with or without distant metastases within 12 months\n2. Tumor size ≤ 7 centimeters in the longest diameter.\n3. Targeted lesion must be technically amenable for complete coverage (including margins) by the Alpha DaRT sources.\n4. Measurable target according to RECIST v1.1\n5. Interstitial implant indication validated by multidisciplinary team.\n6. ECOG Performance Status ≤3.\n7. Life expectancy ≥6 months.\n8. Women Age ≥18\n9. Willing and have the ability to provide signed Informed Consent.\n10. Willing to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.\n11. 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\n1. Concomitant chemotherapy or immunotherapy within the past 4 weeks\n2. Fit for surgical exploration unless the patient refuses surgery\n3. Known hypersensitivity to any of the components of the treatment.\n4. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n5. Longest tumor diameter \\>7 cm.\n6. Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n7. Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n8. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n9. Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of Alpha DaRT.\n10. 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 Alpha DaRT.\n11. High probability of protocol non-compliance (in opinion of investigator).\n12. Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.\n13. Subjects not willing to sign an informed consent","FEMALE",{"count":54,"type":21},[24],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.",[436,437],"Carcinoma of the Vulva","Recurrent Carcinoma of the Vulva",[198,136,61,102],"2024-01-30",{"date":441,"type":36},"2024-01-31",{"date":443,"type":21},"2024-04",{"date":93,"type":21},{"name":42,"class":43},""]