Actively Recruiting
BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
Led by Cardiovascular and Interventional Radiological Society of Europe · Updated on 2025-12-30
50
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
Cardiovascular and Interventional Radiological Society of Europe
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bone metastases in patients with oligometastatic disease (<5 bone/visceral metastases) or bone oligo-progressive disease from solid tumors
- Number of target lesions 4
- Size of target lesion(s) < 5 cm (largest diameter)
- Referral to local ablative treatment by multidisciplinary tumour board
- Treatment planned by percutaneous cryoablation with curative intent assessed as technically feasible
- Procedure performed with a cryoablation system from Boston Scientific
You will not qualify if you...
- Younger than 18 years old
- Unable or unwilling to give informed consent
- Ongoing pregnancy
- Health status not compatible with minimum follow-up of 12 months (Karnofsky Performance Scale < 60%, rapidly evolving tumor histologies with life expectancy < 12 months, or life expectancy < 12 months)
- Infection at treatment site or systemic infection
- Uncorrectable coagulopathy
- Hematological diseases including multiple myeloma and plasmacytoma
- Concomitant radiation therapy or radiation therapy within 12 weeks before planned cryoablation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Institute Bergonié
Bordeaux, France, 33076
Actively Recruiting
2
CHRU de Strasbourg
Strasbourg, France, 67200
Actively Recruiting
3
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
4
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
5
CHUV-Lausanne University Hospital
Lausanne, Switzerland, 1011
Actively Recruiting
Research Team
C
Claire E Poulet, PhD
CONTACT
D
Dhwani S. Korde, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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