BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

NCT06480955 | Recruiting

• 1 other identifier: BOREALIS
• Study Type: observational
• Target: 50
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Bone Metastases

Keywords

Cryoablation Oligo-progressive disease; Bone metastases; Oligometastatic Disease; Oligo-progressive disease

Outcome Measures

Primary Outcomes (1)

• Local progression-free survival rate

  On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate

  12 months

Secondary Outcomes (12)

• Technical feasibility

  Periprocedurally

• Adverse events

  Through study completion

• Complete local tumour response

  12 months

• Fracture-free survival

  End of study

• Fracture-free survival rate

  Until the end of the follow-up period (1 year)

Study Arms (1)

Full cohort

Cryoablation with curative-intent of bone metastases from oligometastatic or bone oligo-progressive disease.

Device: Cryoablation system

Interventions

Cryoablation system DEVICE

Any cryoablation system from Boston Scientific that has received CE Mark and/or FDA clearance for the ablation of bone malignancies.

Full cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bone metastases from oligometastatic or bone oligo-progressing disease from solid tumours treated with curative-intent cryoablation may participate in BOREALIS. Patients from vulnerable populations (e.g., minors, pregnant women, incapacitated or unconscious individuals) shall not be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Cardiovascular and Interventional Radiological Society of Europe: lead
• Boston Scientific Corporation: collaborator

Study Sites (5)

Institute Bergonié

Bordeaux, 33076, France

RECRUITING

CHRU de Strasbourg

Strasbourg, 67200, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

CHUV-Lausanne University Hospital

Lausanne, 1011, Switzerland

RECRUITING

Study Officials

• Roberto L Cazzato, Dr

  Strasbourg University Hospitals, Strasbourg, France

  STUDY CHAIR

Central Study Contacts

Claire E Poulet, PhD

CONTACT

+41 79 385 16 78; borealis@cirse.org

Dhwani S. Korde, PhD

CONTACT

+4367762942469; borealise@cirse.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 28, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); CH (1); FR (3)