BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

Launched by CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE · Jun 25, 2024

Keywords

ClinConnect Summary

The BOREALIS trial is a study that aims to understand how effective and safe a treatment called cryoablation is for patients with bone metastases, which means cancer that has spread to the bones. This trial specifically looks at patients who have a limited number of metastases (less than five) or those whose disease is stable except for one to three progressing bone lesions. The goal of cryoablation is to freeze and destroy the cancer cells in the bones, potentially providing relief from pain and improving quality of life.

To participate in the trial, patients must be between the ages of 65 and 74 and have specific types of bone metastases, with certain criteria regarding the size and number of lesions. They also need to be referred for this treatment by a team of doctors and have a life expectancy of at least 12 months. It's important to note that the trial is not currently recruiting participants, but those who are interested should be aware that the procedure will be conducted using a specialized cryoablation system and will involve regular follow-ups to monitor their health and progress over a year.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Bone metastases in patients with oligometastatic disease (\<5 bone/visceral metastases) or bone oligo-progressive disease (visceral or osseous multi-metastatic disease stable under systemic treatment except 1-3 progressing bone metastases) from solid tumours;
• • Number of target lesions ≤ 3
• • Size of target lesion(s) \< 5 cm (largest diameter);
• • Referral to local ablative treatment by multidisciplinary tumour board (MDTB);
• • Treatment by percutaneous cryoablation with curative intent (i.e., complete tumour destruction) assessed as technically feasible by the IR in charge;
• • Procedure performed with a cryoablation system from Boston Scientific.
• Exclusion Criteria:
• • \< 18 years old;
• • Incapacity or refusal to give informed consent;
• • Ongoing pregnancy;
• * Health status not compatible with the minimum meaningful follow-up period (i.e., 12 months):
• • Karnofsky Performance Scale \< 60%, or
• • Bone metastases originating from rapidly evolving tumour histologies not allowing reasonable life expectancy of at least 12 months, or
• • Life expectancy \< 12 months
• • Infection of treatment site or systemic infection;
• • Uncorrectable coagulopathy;
• • Haematological disease (including multiple myeloma and plasmacytoma);
• • Concomitant radiation therapy or radiation therapy within 12 weeks before the planned cryoablation procedure.