BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe (BOREALIS)

Cardiovascular and Interventional Radiological Society of Europe

Status

Not yet enrolling

Conditions

Bone Metastases

Treatments

Device: Cryoablation system

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06480955

BOREALIS_CIPv1.0

Details and patient eligibility

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.