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Recruiting NCT06480955

BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

— Observational Bone Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryoablation system.
Who it may be relevant to
Registry conditions: Bone Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Spain, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Local progression-free survival rate [Time frame: 12 months]
Secondary outcome measures (12)
  • Technical feasibility [Time frame: Periprocedurally]
  • Adverse events [Time frame: Through study completion]
  • Complete local tumour response [Time frame: 12 months]
  • Fracture-free survival [Time frame: End of study]
  • Fracture-free survival rate [Time frame: Until the end of the follow-up period (1 year)]
  • Bone-disease progression-free survival [Time frame: Until the end of the follow-up period (1 year)]
  • Extraosseous disease progression-free survival [Time frame: Until the end of the follow-up period (1 year)]
  • Overall progression-free survival [Time frame: Until the end of the follow-up period (1 year)]
  • Overall survival [Time frame: Until the end of the follow-up period (1 year)]
  • Systemic therapy-free survival [Time frame: Until the end of the follow-up period (1 year)]
  • Impact on patient pain [Time frame: 1, 3, 6, 12 months]
  • Impact on patient quality of life [Time frame: 1, 3, 6, 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Institute Bergonié — Bordeaux
  • CHRU de Strasbourg — Strasbourg
  • Institut Gustave Roussy — Villejuif
Spain · 1 center
  • Hospital Universitario y Politécnico La Fe — Valencia
Switzerland · 1 center
  • CHUV-Lausanne University Hospital — Lausanne

Identifiers

NCT: NCT06480955 · BOREALIS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗