Cryoablation system: Any cryoablation system from Boston Scientific that has received CE Mark and/or FDA clearance for the ablation of bone malignancies.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Local progression-free survival rate — 12 months On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate
Trial sites (5)
Facility
City
Region
Status
Institute Bergonié
Bordeaux
France
Recruiting
CHRU de Strasbourg
Strasbourg
France
Recruiting
Institut Gustave Roussy
Villejuif
France
Recruiting
Hospital Universitario y Politécnico La Fe
Valencia
Spain
Recruiting
CHUV-Lausanne University Hospital
Lausanne
Switzerland
Recruiting
More Cardiovascular and Interventional Radiological Society of Europe trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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