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Clinical trial Recruiting at 5 sites Observational Ages 18 and up

Curative cryoablation for up to three bone metastases

Official title: BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

Run by Cardiovascular and Interventional Radiological Society of Europe · NCT06480955 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorCardiovascular and Interventional Radiological Society of Europe
Academic / other
Drugs / interventionsradiation
Locations5 sites (Bordeaux and 4 other locations)
StatusRecruiting
StartedApril 1, 2025
Main results expectedApril 2027
Study endsApril 2028
Registry record updatedDecember 30, 2025
Trial IDNCT06480955 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Bone Metastases 25Cardiovascular and Interventional Radiological Society of Europe 3
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.