Bone MetastasesBOREALISNCT06480955
BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
An observational study of Bone Metastases, run by Cardiovascular and Interventional Radiological Society of Europe at 5 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Cryoablation system
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Apr 2025to Apr 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bone metastases from oligometastatic or bone oligo-progressing disease from solid tumours treated with curative-intent cryoablation may participate in BOREALIS. Patients from vulnerable populations (e.g., minors, pregnant women, incapacitated or unconscious individuals) shall not be included in the study.
Who may be able to join
- 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.
Who cannot join
- < 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
Show all 11Show fewer
- 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.
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
France3 sites, 3 recruiting
- Recruiting
Institute Bergonié
Bordeaux, 33076
Xavier Buy, Dr
- Recruiting
CHRU de Strasbourg
Strasbourg, 67200
Roberto Luigi Cazzato, Dr
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Frederic Deschamps, Dr
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Fernando Gómez Muñoz, Dr
Switzerland1 site, 1 recruiting
- Recruiting
CHUV-Lausanne University Hospital
Lausanne, 1011
Georgia Tsoumakidou, Dr
About this study
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.
- Conditions
- Bone Metastases
- Being tested
- Cryoablation system
- Keywords
- Cryoablation Oligo-progressive disease, Bone metastases, Oligometastatic Disease, Oligo-progressive disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation systemDevice
Any cryoablation system from Boston Scientific that has received CE Mark and/or FDA clearance for the ablation of bone malignancies.
| Study group | Role | What they receive |
|---|---|---|
| Full cohort | Cryoablation with curative-intent of bone metastases from oligometastatic or bone oligo-progressive disease. Receives: Device: Cryoablation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local progression-free survival rate
On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate
Measured: 12 months
Secondary outcomes (12)
Technical feasibility
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
Measured: Periprocedurally
Adverse events
Incidence and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Through study completion
Complete local tumour response
On a per lesion basis, proportion of target lesions with complete response status
Measured: 12 months
Fracture-free survival
On a per lesion basis,time between cryoablation and fracture at treated site
Measured: End of study
Fracture-free survival rate
On a per lesion basis, proportion of target lesion(s) free from fracture
Measured: Until the end of the follow-up period (1 year)
Bone-disease progression-free survival
Time between cryoablation and progression in the bone (incl. new lesions)
Measured: Until the end of the follow-up period (1 year)
Extraosseous disease progression-free survival
Time between cryoablation and extra-osseous progression (incl. new lesions)
Measured: Until the end of the follow-up period (1 year)
Overall progression-free survival
Time between cryoablation and any progression (incl. new lesions) or death
Measured: Until the end of the follow-up period (1 year)
Overall survival
Time between cryoablation and death
Measured: Until the end of the follow-up period (1 year)
Systemic therapy-free survival
Time between cryoablation and the next systemic treatment (excluding any adjuvant treatment that was part of the patient's treatment plan)
Measured: Until the end of the follow-up period (1 year)
Impact on patient pain
Patient-reported pain assessment using the Brief Pain Inventory - short form
Measured: 1, 3, 6, 12 months
Impact on patient quality of life
Patient-reported quality of life assessment using the EORTC QLQ-C30 questionnaire
Measured: 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of Europe
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Roberto L Cazzato, Dr, Study chair, Strasbourg University Hospitals, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480955
- Sponsor's protocol ID
- BOREALIS
- Acronym
- BOREALIS
- Status last verified
- Dec 2025
- First submitted
- 19 Jun 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cazzato RL, Buy X, Gomez F, Deschamps F, Arnold D, Filippiadis D, Jennings J, Schaefer N, Schneegans O, Tsoumakidou G, Zeka B, Poulet C, Kaufmann N, Palussiere J, Gangi A. Curative-Intent Cryoablation for Bone Metastases: Study Protocol for BOREALIS, a Prospective Multicentre Observational Investigation. Cardiovasc Intervent Radiol. 2026 Aug 19. doi: 10.1007/s00270-026-04550-z. Online ahead of print.
PubMed 42618654
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
- ClinicalTrials.gov ID
- NCT06480955
- Acronym / sponsor ID
- BOREALIS / BOREALIS
- Conditions
- Bone Metastases
- Keywords
- Cryoablation Oligo-progressive disease, Bone metastases, Oligometastatic Disease, Oligo-progressive disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of EuropeUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full cohort | – | Device: Cryoablation systemCryoablation with curative-intent of bone metastases from oligometastatic or bone oligo-progressive disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bone metastases from oligometastatic or bone oligo-progressing disease from solid tumours treated with curative-intent cryoablation may participate in BOREALIS. Patients from vulnerable populations (e.g., minors, pregnant women, incapacitated or unconscious individuals) shall not be included in the study.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- < 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):
- Infection of treatment site or systemic infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation systemAny cryoablation system from Boston Scientific that has received CE Mark and/or FDA clearance for the ablation of bone malignancies. | Device | Full cohort |
Primary outcome
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 42618654Cazzato RL, Buy X, Gomez F, Deschamps F, Arnold D, Filippiadis D, Jennings J, Schaefer N, Schneegans O, Tsoumakidou G, Zeka B, Poulet C, Kaufmann N, Palussiere J, Gangi A. Curative-Intent Cryoablation for Bone Metastases: Study Protocol for BOREALIS, a Prospective Multicentre Observational Investigation. Cardiovasc Intervent Radiol. 2026 Aug 19. doi: 10.1007/s00270-026-04550-z. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto L Cazzato, Dr study chair
Strasbourg University Hospitals, Strasbourg, France
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases, run by Cardiovascular and Interventional Radiological Society of Europe at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire E Poulet, PhD (+41 79 385 16 78, borealis@cirse.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local progression-free survival rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.