RecruitingNCT06480955

BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

Sponsor

Cardiovascular and Interventional Radiological Society of Europe

Enrollment

50 participants

Start Date

Apr 1, 2025

Study Type

OBSERVATIONAL

Conditions

Bone Metastases

Summary

BOREALIS is a multicentre, prospective, observational cohort study designed to investigate the effectiveness, feasibility, safety and impact on pain and quality of life of curative-intent cryoablation for the treatment of bone metastases in patients with oligometastatic or bone oligo-progressive disease.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria11

< 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.