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BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

Recruitingn/aAges 18 Years - anyAllCardiovascular and Interventional Radiological So…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Cryoablation system
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Where

5 sites
Institute Bergonié
Bordeaux, France
CHRU de Strasbourg
Strasbourg, France
Institut Gustave Roussy
Villejuif, France
Hospital Universitario y Politécnico La Fe
Valencia, Spain
CHUV-Lausanne University Hospital
Lausanne, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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