An interventional study of DaRT- Diffusing Alpha-emitters Radiation Therapy in Skin Cancer, Cutaneous Tumor and Cutaneous Metastasis, sponsored by Alpha Tau Medical LTD.. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Alpha Tau Medical LTD. · Not applicable, Interventional, and Treatment
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.
This 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.
Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.
Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's planned enrollment of 80 is above the median of 53 across 416 interventional studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →Alpha Tau Medical LTD. is the lead sponsor of 28 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
Acceptable tumor locations include the following:
Exclusion Criteria:
Subject has a tumor with histology of one of the following:
An intratumoral insertion of securely fixed seeds loaded with Radium-224. The seeds release by recoil short-lived alpha-emitting atoms into the tumor.
Device: DaRT- Diffusing Alpha-emitters Radiation Therapy
Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles
The objective response rate to DaRT treatment
Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Time frame: up to 9-11 weeks
Tumor volume
Assessment of the reduction in tumor volume based on imaging tests
Time frame: up to 9-11 weeks
DaRT seeds placement
Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging
Time frame: Day of DaRT insertion procedure
Change in quality of life as assessed by the Skindex-16 questionnaire
Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skindex-16 questionnaire
Time frame: up to 9-11 weeks
Disease-Free Survival (DFS) rate
Assessment of Disease-Free Survival
Time frame: up to 24 months
Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire
Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skin Cancer Index (SCI) questionnaire.
Time frame: up to 9-11 weeks
Adverse Events
Assessment of the frequency, severity and causality of adverse events related and not 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.
Time frame: up to 24 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alpha Tau Medical LTD.