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
52 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
Researchers are investigating the use of cryoablation with curative intent to treat bone metastases in patients who have either oligometastatic disease or bone oligo-progressive disease. This observational study aims to assess the effectiveness, feasibility, safety, and impact of this treatment on pain and quality of life. The study is conducted by the Cardiovascular and Interventional Radiological Society of Europe and focuses on patients with limited metastatic bone lesions from solid tumors. Participants will undergo percutaneous cryoablation using a cryoablation system from Boston Scientific that has regulatory approval for treating bone malignancies. The treatment targets up to three bone lesions smaller than 5 cm in diameter. The decision for treatment and technical feasibility is determined by a multidisciplinary tumor board and interventional radiologist. The study does not involve a control or comparator group as it is observational. During the study, participants will be monitored for local progression-free survival at 12 months as the primary outcome. Secondary outcomes include technical feasibility, adverse events, complete tumor response, fracture-free survival, disease progression-free survival, overall survival, and impact on pain and quality of life measured at 1, 3, 6, and 12 months. The follow-up period extends for at least one year, ensuring comprehensive safety and effectiveness data collection.
CONDITIONS
Brief 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 tumours
- Number of target lesions 64 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 assessed as technically feasible by the interventional radiologist
- Procedure performed with a cryoablation system from Boston Scientific
You will not qualify if you...
- Younger than 18 years old
- Incapacity or refusal to give informed consent
- Ongoing pregnancy
- Health status incompatible with minimum meaningful follow-up period (12 months), including Karnofsky Performance Scale < 60%, rapidly evolving tumour histologies, 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 planned cryoablation procedure
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment procedure
Participants undergo percutaneous cryoablation treatment of bone metastases using a cryoablation system from Boston Scientific.
1 treatment visit (in-person)
Duration - Up to 12 months
Participants are monitored for up to 12 months after treatment to assess local tumor response, progression-free survival, fracture-free survival, overall survival, and impact on pain and quality of life.
Visits at 1, 3, 6, and 12 months post-treatment
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
D
Dhwani S. Korde, PhD
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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