Study Evaluating Intratumoral Diffusing Alpha Radiation Emitters for Treating Malignant Skin, Oral Mucosal, or Superficial Soft Tissue Tumors

What this Trial Is About

Researchers are evaluating a novel cancer treatment using an intratumoral diffusing alpha radiation emitter device for patients with malignant skin, oral mucosal, or superficial soft tissue tumors. This prospective, open-label, single-arm study aims to assess the safety and effectiveness of this approach, which combines local intratumoral irradiation with alpha radiation emitted by radioactive seeds placed directly into the tumor. The study focuses on superficial lesions confirmed to be malignant by pathology. Participants receive treatment with Diffusing Alpha Radiation Emitters Therapy DaRT by inserting radioactive seeds loaded with Radium-224 directly into the tumor. These seeds emit short-lived alpha particles within the tumor to target cancer cells. Tumors must be no larger than 7 centimeters and suitable for complete coverage by the seeds, which are placed in a single procedure. The study evaluates tumor size reduction around 9 to 11 weeks after treatment and monitors safety for up to 24 months. Quality of life and progression-free survival are also measured at multiple time points. Throughout the study, participants undergo assessments including tumor response evaluation, tumor volume measurements, and quality of life questionnaires at various intervals up to 180 days post-treatment. Safety is closely monitored by tracking adverse events for up to two years. The placement of the DaRT seeds is documented on the day of the procedure. Participants remain involved in follow-up visits to assess treatment effects and overall health, with the total duration extending up to 24 months after seed insertion.

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