An observational study in Bone Metastases, sponsored by Cardiovascular and Interventional Radiological Society of Europe. Recruiting at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Cardiovascular and Interventional Radiological Society of Europe · Observational
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.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 50 is below the median of 136 across 557 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Cardiovascular and Interventional Radiological Society of Europe is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Health status not compatible with the minimum meaningful follow-up period (i.e., 12 months):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cryoablation with curative-intent of bone metastases from oligometastatic or bone oligo-progressive disease.
Device: Cryoablation system
Any cryoablation system from Boston Scientific that has received CE Mark and/or FDA clearance for the ablation of bone malignancies.
Local progression-free survival rate
On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate
Time frame: 12 months
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
Time frame: Periprocedurally
Adverse events
Incidence and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Through study completion
Complete local tumour response
On a per lesion basis, proportion of target lesions with complete response status
Time frame: 12 months
Fracture-free survival
On a per lesion basis,time between cryoablation and fracture at treated site
Time frame: End of study
Fracture-free survival rate
On a per lesion basis, proportion of target lesion(s) free from fracture
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Until the end of the follow-up period (1 year)
Overall survival
Time between cryoablation and death
Time frame: 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)
Time frame: 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
Time frame: 1, 3, 6, 12 months
Impact on patient quality of life
Patient-reported quality of life assessment using the EORTC QLQ-C30 questionnaire
Time frame: 1, 3, 6, 12 months
Plan to share: No
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Cardiovascular and Interventional Radiological Society of Europe