NCT04068155 Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
| NCT ID | NCT04068155 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alpha Tau Medical LTD. |
| Condition | Skin Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-04-01 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
Eligibility Criteria
Inclusion Criteria: * Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies: * SCC * BCC * Lentigo maligna melanoma (Dubreuilh melanoma) * Carcinosarcoma * Acceptable tumor locations include the following: * Skin (facial, scalp, extremities, torso) * Lips * Eyelids * Subjects with a tumor size ≤ 7 centimeters in the longest diameter. * Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds. * Measurable disease according to RECIST v1.1. * Subjects over 18 years old. * Subjects' ECOG Performance Status Scale is \< 2. * Subjects' life expectancy is more than 6 months. * Platelet count ≥100,000/mm3. * International normalized ratio of prothrombin time ≤1.8. * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test. * Subjects are willing to sign an informed consent form Exclusion Criteria: * Subject has a tumor with histology of one of the following: * Keratoacanthoma * Merkel cell carcinoma * Sarcoma other than carcinosarcoma * Metastatic disease (according to the TNM staging system - M1 patients are excluded) * 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.). * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids. * 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. * High probability of protocol non-compliance (in opinion of investigator). * Subjects not willing to sign an informed consent. * Women who are pregnant or breastfeeding.
Contact & Investigator
Dr Pascal POMMIER
PRINCIPAL INVESTIGATOR
Centre Leon Berard
Frequently Asked Questions
Who can join the NCT04068155 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Skin Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04068155 currently recruiting?
Yes, NCT04068155 is actively recruiting participants. Contact the research team at LironD@alphatau.com for enrollment information.
Where is the NCT04068155 trial being conducted?
This trial is being conducted at Grenoble, France, Lyon, France.
Who is sponsoring the NCT04068155 clinical trial?
NCT04068155 is sponsored by Alpha Tau Medical LTD.. The principal investigator is Dr Pascal POMMIER at Centre Leon Berard. The trial plans to enroll 80 participants.
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