Curative cryoablation for up to three bone metastases
BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
This prospective registry will try cryoablation with curative intent to treat up to three bone metastases in adults with oligometastatic or oligo-progressive solid tumors and record effects on pain, quality of life, safety, and tumor control.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiovascular and Interventional Radiological Society of Europe Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Bordeaux and 4 other locations) |
| Trial ID | NCT06480955 on ClinicalTrials.gov |
What this trial studies
BOREALIS is a multicentre, prospective observational cohort collecting real-world data on percutaneous cryoablation performed with a Boston Scientific system for curative-intent treatment of bone metastases. Eligible adults have oligometastatic or bone oligo-progressive disease with up to three target lesions smaller than 5 cm and are referred by a multidisciplinary tumour board. The registry records feasibility, procedural safety, local tumor control, pain scores, and quality-of-life outcomes with a minimum meaningful follow-up of 12 months. Data are gathered across participating French centres to inform outcomes of curative-intent bone cryoablation in routine practice.
Who should consider this trial
Good fit: Adults with solid-tumor bone metastases limited to oligometastatic disease or bone oligo-progressive disease, with up to three target lesions each under 5 cm and judged technically feasible for percutaneous cryoablation by the treating interventional radiologist after MDT board referral.
Not a fit: Patients with widespread metastatic disease, more than three target lesions, lesions larger than 5 cm, rapidly progressive histologies, poor performance status (Karnofsky < 60%), pregnancy, or inability to consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide durable local tumor control, reduce pain, and improve quality of life while avoiding more extensive treatments.
How similar studies have performed: Smaller single-center series and registries have reported good local control and pain relief after bone cryoablation, but prospective multicentre data on curative-intent use remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bordeaux and 4 other locations
- 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)
Study contacts
- Study coordinator: Claire E Poulet, PhD
- Email: borealis@cirse.org
- Phone: +41 79 385 16 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.