Study on Safety and Feasibility of Using Diffusing Alpha Radiation Seeds to Treat Liver Metastases

What this Trial Is About

Researchers are evaluating the feasibility and safety of Diffusing Alpha Radiation Emitters Therapy DaRT for treating liver metastases from colorectal cancer. This prospective, open-label, single-center study aims to determine the ability to fully cover liver metastases with the DaRT seeds and monitor safety according to standardized criteria. Secondary goals include assessing pathological and radiological responses of the liver metastases after treatment. Participants receive intratumoral implantation of DaRT seeds, which emit alpha particles to target solid tumors. The DaRT device consists of radioactive sources coated with radium-224 inserted directly into liver metastases. This study involves one treatment arm where all participants receive the DaRT intervention. The study measures feasibility over 24 months from seed placement and evaluates responses 6 to 9 weeks after treatment. During the trial, participants undergo clinical assessments including imaging scans to measure tumor size and pathological evaluation according to tumor regression grades. Safety is monitored for up to 24 months post-treatment, with adverse events recorded. Participants must meet specific health and laboratory criteria before enrollment and sign informed consent. Overall, the study spans treatment and extended follow-up periods to evaluate outcomes and safety over time.

Alpha Radiation Emitters Device (DaRT) for the Treatment of Liver Metastases