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NCT Number: NCT06480955

BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute Bergonié, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryoablation system

Device

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

Primary outcomes

  1. Local progression-free survival rate

    Time frame: 12 months

    On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate

Secondary outcomes

  1. Technical feasibility

    Time frame: Periprocedurally

    Adherence to a comprehensive SOC treatment protocol that includes i) peri-operative biopsy if indicated, ii) cryoablation, and iii) bone consolidation through osteoplasty or osteosynthesis if biomechanically indicated

  2. Adverse events

    Time frame: Through study completion

    Incidence and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  3. Complete local tumour response

    Time frame: 12 months

    On a per lesion basis, proportion of target lesions with complete response status

  4. Fracture-free survival

    Time frame: End of study

    On a per lesion basis,time between cryoablation and fracture at treated site

  5. Fracture-free survival rate

    Time frame: Until the end of the follow-up period (1 year)

    On a per lesion basis, proportion of target lesion(s) free from fracture

  6. Bone-disease progression-free survival

    Time frame: Until the end of the follow-up period (1 year)

    Time between cryoablation and progression in the bone (incl. new lesions)

  7. Extraosseous disease progression-free survival

    Time frame: Until the end of the follow-up period (1 year)

    Time between cryoablation and extra-osseous progression (incl. new lesions)

  8. Overall progression-free survival

    Time frame: Until the end of the follow-up period (1 year)

    Time between cryoablation and any progression (incl. new lesions) or death

  9. Overall survival

    Time frame: Until the end of the follow-up period (1 year)

    Time between cryoablation and death

  10. Systemic therapy-free survival

    Time frame: Until the end of the follow-up period (1 year)

    Time between cryoablation and the next systemic treatment (excluding any adjuvant treatment that was part of the patient's treatment plan)

  11. Impact on patient pain

    Time frame: 1, 3, 6, 12 months

    Patient-reported pain assessment using the Brief Pain Inventory - short form

  12. Impact on patient quality of life

    Time frame: 1, 3, 6, 12 months

    Patient-reported quality of life assessment using the EORTC QLQ-C30 questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Claire E Poulet, PhD

CONTACT

[email protected]

+41 79 385 16 78

Dhwani S. Korde, PhD

CONTACT

[email protected]

+4367762942469

Sponsors and collaborators

Lead sponsor

Cardiovascular and Interventional Radiological Society of Europe

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Acronym: BOREALIS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 28, 2024
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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