An interventional study of Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in Skin Cancer, Mucosal Neoplasm of Oral Cavity and Soft Tissue Neoplasm, sponsored by Alpha Tau Medical LTD.. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
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 superficial cutaneous, mucosal or soft tissue neoplasia
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.
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.
Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.
Reduction in tumor volume and evaluation the percent of necrotic tissue in the tumor 30-45 days after DaRT seeds insertion (15-30 days after seed removal) will be assessed. Safety will be assessed by the cumulative incidence, worst severity and frequency of adverse events (AEs) observed including the follow-up period.
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's enrollment of 2 is below 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.
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Exclusion Criteria:
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
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.
Evaluate the safety of the DaRT treatment
The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).
Time frame: 5-7 weeks after DaRT seed insertion.
Evaluation the effectiveness of the treatment.
Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.
Time frame: Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT.
Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic
Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic tissue present in the remaining tumor tissue surgically removed 15-30 days after removal of DaRT seeds.
Time frame: 15-30 days after removal of DaRT seeds.
Plan to share: No
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This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Alpha Tau Medical LTD.