Evaluation of Intratumoral Alpha Radiation Device for Treating Malignant Skin Tumors Using DaRT Seeds

What this Trial Is About

Researchers are studying a new approach for treating malignant cutaneous tumors using an intratumoral diffusing alpha radiation emitter device called DaRT. This prospective, open-label, single-arm, multi-center study aims to assess the safety and effectiveness of DaRT, which delivers alpha radiation through radioactive seeds inserted directly into the tumor. The study focuses on treating skin lesions confirmed as malignant, including various types of skin cancer, and evaluates tumor response and safety outcomes. Participants will receive DaRT treatment involving the insertion of seeds loaded with Radium-224 into the tumor. These seeds release short-lived alpha-emitting atoms to irradiate the tumor locally. The treatment is designed to combine the advantages of localized radiation with the powerful effects of alpha particles at much lower radiation doses than conventional therapies. The study will monitor tumor size reduction 9 to 11 weeks after the DaRT insertion. During the study, participants will undergo assessments including tumor measurement according to RECIST criteria, quality of life questionnaires like Skindex-16 and Skin Cancer Index, and safety monitoring through adverse event reporting. Disease-Free Survival will be followed for up to 24 months. Researchers will also evaluate the placement of DaRT seeds on the day of insertion. Participants are expected to be involved in multiple visits for these evaluations over the treatment and follow-up periods.

Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors