Registry Study on Cryoablation Treatment for Bone Metastases in Patients with Oligometastatic or Oligo-Progressive Solid Tumors

What this Trial Is About

Researchers are investigating the use of cryoablation with curative intent to treat bone metastases in patients who have either oligometastatic disease or bone oligo-progressive disease. This observational study aims to assess the effectiveness, feasibility, safety, and impact of this treatment on pain and quality of life. The study is conducted by the Cardiovascular and Interventional Radiological Society of Europe and focuses on patients with limited metastatic bone lesions from solid tumors. Participants will undergo percutaneous cryoablation using a cryoablation system from Boston Scientific that has regulatory approval for treating bone malignancies. The treatment targets up to three bone lesions smaller than 5 cm in diameter. The decision for treatment and technical feasibility is determined by a multidisciplinary tumor board and interventional radiologist. The study does not involve a control or comparator group as it is observational. During the study, participants will be monitored for local progression-free survival at 12 months as the primary outcome. Secondary outcomes include technical feasibility, adverse events, complete tumor response, fracture-free survival, disease progression-free survival, overall survival, and impact on pain and quality of life measured at 1, 3, 6, and 12 months. The follow-up period extends for at least one year, ensuring comprehensive safety and effectiveness data collection.

BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe