BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Full cohort

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

Cryoablation system

Intervention Type DEVICE

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

Interventions

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Cryoablation system

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No