BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCardiovascular and Interventional Radiological Society of Europe

About this trial

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

Qualifiers

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);

Disqualifiers

< 18 years old;

Incapacity or refusal to give informed consent;

Ongoing pregnancy;

Karnofsky Performance Scale < 60%, or

Trial design

Treatments tested in this trial

  • Cryoablation system

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

5
France
Institute Bergonié33076, Bordeaux France
CHRU de Strasbourg67200, Strasbourg France
Institut Gustave Roussy94805, Villejuif France
Spain
Hospital Universitario y Politécnico La Fe46026, Valencia Spain

Sponsors and collaborators

Cardiovascular and Interventional Radiological Society of Europe

Lead sponsor

Boston Scientific Corporation

Collaborator