Cardiovascular and interventional radiology
August 19, 2026 · via Europe PMC
Curative-Intent Cryoablation for Bone Metastases: Study Protocol for BOREALIS, a Prospective Multicentre Observational Investigation.
Cazzato RL, Buy X, Gomez F, +11 more, Gangi A.
AI summary — for doctors, generated from the abstract only
This is a study protocol for BOREALIS, a prospective multicentre registry of curative-intent cryoablation for bone metastases; no results are reported.
What was studied
Protocol of an observational cohort (NCT06480955) following participants with bone metastases for 1 year after cryoablation performed with curative intent. The abstract's Methods are truncated after 'up to 50 participants', so eligibility criteria and endpoints are not shown.
Key findings
- Cryoablation is established as palliative treatment for painful bone metastases, but data on curative potential are scarce and mostly small retrospective studies
- BOREALIS plans to follow up to 50 participants for 1 year
- The aim is to inform future clinical guidelines on curative-intent cryoablation
Clinical relevance
If completed, it could provide prospective real-world evidence on whether cryoablation can clear bone metastases in selected oligometastatic patients.
Who should care
Limitations
No outcome data exist yet; the planned sample of up to 50 is small and the design is observational without a comparator. Details are cut off in the abstract.
A protocol only; wait for results before changing practice.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Purpose
Cryoablation (CA) is a well-established, safe and effective palliative treatment for painful bone metastases (BM). Data exploring its curative potential (i.e. radical clearing of the target lesion) is however very scarce, mostly coming from small retrospective studies. The BOne metastases REgistry for patients undergoing cryoAbLation with curatIve purpoSe (BOREALIS) aims to address this shortcoming by collecting prospective, multicentric real-world data on the outcomes of curative-intent CA for bone metastases.
Methods
BOREALIS is an observational cohort study designed to follow for 1 year up to 50 participants with BM (< 5 cm) from oligometastatic or bone oligo-progressive disease treated with curative-intent CA. The primary outcome measure is the 12-months local progression-free survival rate, assessed per lesion using the newly developed BOREALIS tumour response criteria. Secondary outcome measures include complete response rate, fracture-free, progression-free, and overall survival; safety; patient-reported pain; and health-related quality of life (HRQoL). The study will also evaluate the feasibility of a comprehensive procedure integrating, when indicated, biopsy and bone consolidation within the same CA session. Results will be reported using mainly descriptive statistics. Patient enrolment opened in April 2025.
Conclusion
BOREALIS intends to provide insights into the effectiveness of curative-intent CA for BM to inform the development of future clinical guidelines. BOREALIS is registered on ClinicalTrial.gov (NCT06480955).
DOI
10.1007/s00270-026-04550-z
PMID
42618654
PMCID
PMC13642440
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
Want more like this?
Browse more from the feed. A free account unlocks the full feed, saving and communities.
Back to the research feed