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BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

NCT ID: NCT06480955

Last Updated: 2024-06-28

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

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2027-11-30

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.

Detailed Description

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Conditions

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Bone Metastases

Keywords

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Cryoablation Oligo-progressive disease Bone metastases Oligometastatic Disease Oligo-progressive disease

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

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Cardiovascular and Interventional Radiological Society of Europe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roberto L Cazzato, Dr

Role: STUDY_CHAIR

Strasbourg University Hospitals, Strasbourg, France

Central Contacts

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Claire E Poulet, PhD

Role: CONTACT

Phone: +43 1904 2003 71

Email: [email protected]

Other Identifiers

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BOREALIS_CIPv1.0

Identifier Type: -

Identifier Source: org_study_id