Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT03737734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-07
First Post:
2018-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012983', 'term': 'Soft Tissue Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D012514', 'term': 'Sarcoma, Kaposi'}, {'id': 'D014062', 'term': 'Tongue Neoplasms'}, {'id': 'D008048', 'term': 'Lip Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014060', 'term': 'Tongue Diseases'}, {'id': 'D008047', 'term': 'Lip Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor response to DaRT', 'timeFrame': '9-11 weeks post DaRT insertion', 'description': 'Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 24 Months', 'description': 'The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.'}], 'secondaryOutcomes': [{'measure': 'Reduction in tumor volume', 'timeFrame': '9-11 weeks post DaRT insertion', 'description': 'based on imaging'}, {'measure': 'DaRT seeds placement', 'timeFrame': 'Day of insertion procedure', 'description': 'Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion'}, {'measure': 'Change in quality of life', 'timeFrame': 'Day 15, Day 30, Day 70, Day 180 post DaRT insertion', 'description': 'Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score'}, {'measure': 'Change in quality of life', 'timeFrame': 'Day 30, Day 70, Day 180 post DaRT insertion', 'description': 'Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 24 Months', 'description': 'All Adverse Events (AE) related and unrelated to the study treatment'}, {'measure': 'Progression Free Survival', 'timeFrame': '24 months post DaRT insertion', 'description': 'Time elapsed from response to disease progression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Squamous Cell Carcinoma', 'SCC', 'Skin Cancer', 'Skin metastasis', 'HNSCC', 'Carcinoma, Squamous', 'CMN', 'Basal cell carcinoma', 'Superficial sarcoma', 'Kaposi sarcoma', 'Alpha radiation', 'Cutaneous lesion', 'Tongue cancer', 'Lip cancer', 'Brachytherapy'], 'conditions': ['Skin Cancer', 'Mucosal Neoplasm of Oral Cavity', 'Soft Tissue Neoplasm']}, 'descriptionModule': {'briefSummary': 'A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia', 'detailedDescription': 'This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.\n\nThis approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.\n\nSuperficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.\n\nReduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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* 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* Subjects' ECOG Performance Status Scale is \\< 2.\n* Subjects' life expectancy is more than 6 months.\n* Platelet count ≥100,000/mm3.\n* International normalized ratio of prothrombin time ≤1.8.\n* Creatinine ≤1.9 mg/dL.\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* Women who are pregnant or breastfeeding."}, 'identificationModule': {'nctId': 'NCT03737734', 'briefTitle': 'Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alpha Tau Medical LTD.'}, 'officialTitle': 'A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia', 'orgStudyIdInfo': {'id': 'CTP-CMN-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DaRT Seeds', 'description': 'Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds', 'interventionNames': ['Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)']}], 'interventions': [{'name': 'Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)', 'type': 'DEVICE', 'otherNames': ['DaRT'], 'description': '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.', 'armGroupLabels': ['DaRT Seeds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Davidof Cancer Institution at the Rabin Medical Center Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Noga Kurman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Davidof Cancer Institution at Rabin Medical Center Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alpha Tau Medical LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}