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Clinical Trials in Switzerland / NCT06480955
Recruiting Observational

BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

NCT06480955 · tracked via the Priya Life Science Switzerland tracker
Phase
Observational
Started
2025-04-01
Last updated
2025-12-30

Condition(s) studied

Bone Metastases

Investigational drug(s) / intervention(s)

Cryoablation system

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)

Trial sites (5)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06480955 on ClinicalTrials.gov ↗ ← All trials in Switzerland