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.
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);
< 18 years old;
Incapacity or refusal to give informed consent;
Ongoing pregnancy;
Karnofsky Performance Scale < 60%, or
Patients with bone metastases from oligometastatic or bone oligo-progressing disease from solid tumours treated with curative-intent cryoablation may participate in BOREALIS. Patients from vulnerable populations (e.g., minors, pregnant women, incapacitated or unconscious individuals) shall not be included in the study.
Cohort
Prospective
Cryoablation system
DeviceAny cryoablation system from Boston Scientific that has received CE Mark and/or FDA clearance for the ablation of bone malignancies.
Local progression-free survival rate
On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate
Technical feasibility
Adherence to a comprehensive SOC treatment protocol that includes i) peri-operative biopsy if indicated, ii) cryoablation, and iii) bone consolidation through osteoplasty or osteosynthesis if biomechanically indicated
Adverse events
Incidence and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Complete local tumour response
On a per lesion basis, proportion of target lesions with complete response status
Fracture-free survival
On a per lesion basis,time between cryoablation and fracture at treated site
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Cardiovascular and Interventional Radiological Society of Europe
Lead sponsor
Boston Scientific Corporation
Collaborator
