A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

What this Trial Is About

Researchers are evaluating a novel cancer treatment using an intratumoral diffusing alpha radiation emitter device for malignant cutaneous, mucosal, or superficial soft tissue tumors. This prospective, open-label, single-arm study aims to assess the safety and effectiveness of this treatment, which combines local tumor irradiation with alpha radiation emitted from radioactive seeds inserted directly into tumors. The study focuses on superficial lesions confirmed to be malignant through histopathology. The treatment involves inserting seeds loaded with Radium-224 into the tumor, where they release short-lived alpha-emitting atoms to irradiate the tumor locally. This approach uses lower quantities of radiation compared to conventional therapy. The study includes one treatment arm using these diffusing alpha radiation therapy (DaRT) seeds. Tumor response and safety will be monitored approximately 9 to 11 weeks after seed insertion. Participants will undergo tumor size assessments 70 days post-treatment to evaluate response, along with safety monitoring based on the incidence and severity of adverse events. Additional assessments include tumor volume reduction, quality of life evaluations at screening, seed removal, and day 70 visits, and confirmation of proper seed placement. Patient involvement spans from initial screening through follow-up visits and safety evaluations lasting up to 11 weeks after treatment.

Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.