About this trial
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 criteria
Qualifiers
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);
Disqualifiers
< 18 years old;
Incapacity or refusal to give informed consent;
Ongoing pregnancy;
Karnofsky Performance Scale < 60%, or
Trial design
Treatments tested in this trial
- Cryoablation system
Treatment groups
Sponsors and collaborators
Cardiovascular and Interventional Radiological Society of Europe
Lead sponsor
Boston Scientific Corporation
Collaborator