Treatment of malignant skin tumors using alpha radiation emitters
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors
This study is testing a new treatment that uses special radiation to shrink malignant skin tumors in people who have confirmed skin cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alpha Tau Medical LTD. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 2 sites (Grenoble and 1 other locations) |
| Trial ID | NCT04068155 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a novel treatment for malignant cutaneous tumors using a device that delivers diffusing alpha radiation emitters (DaRT) directly into the tumor. The study is prospective, open-label, and single-arm, involving multiple centers. Participants will have confirmed malignant skin lesions, and the treatment aims to reduce tumor size within 9-11 weeks following the insertion of radioactive seeds. Safety will be monitored through the assessment of adverse events.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histopathologically confirmed malignant cutaneous lesions such as squamous cell carcinoma or basal cell carcinoma, and tumors that are amenable to treatment with DaRT.
Not a fit: Patients with tumors larger than 7 centimeters or those with certain health conditions that prevent them from undergoing the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a targeted and effective option for patients with malignant skin tumors, potentially leading to better outcomes and fewer side effects compared to traditional therapies.
How similar studies have performed: While the use of alpha radiation for cancer treatment is a novel approach, similar localized radiation therapies have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grenoble and 1 other locations
- CHU Grenoble Alpes — Grenoble, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Dr Pascal POMMIER — Centre Leon Berard
- Study coordinator: Liron Dimnik
- Email: LironD@alphatau.com
- Phone: +972-2-373-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.