NCT06480955 BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
| NCT ID | NCT06480955 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cardiovascular and Interventional Radiological Society of Europe |
| Condition | Bone Metastases |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-04-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Roberto L Cazzato, Dr
STUDY CHAIR
Strasbourg University Hospitals, Strasbourg, France
Frequently Asked Questions
Who can join the NCT06480955 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06480955 currently recruiting?
Yes, NCT06480955 is actively recruiting participants. Contact the research team at borealis@cirse.org for enrollment information.
Where is the NCT06480955 trial being conducted?
This trial is being conducted at Bordeaux, France, Strasbourg, France, Villejuif, France, Valencia, Spain and 1 additional location.
Who is sponsoring the NCT06480955 clinical trial?
NCT06480955 is sponsored by Cardiovascular and Interventional Radiological Society of Europe. The principal investigator is Roberto L Cazzato, Dr at Strasbourg University Hospitals, Strasbourg, France. The trial plans to enroll 50 participants.