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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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>BOREALIS is an observational cohort study designed to follow for 1\u00a0year up to 50 participants with BM (&lt;\u20095\u00a0cm) 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00270-026-04550-z","type":"journal-article","created":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T19:21:53Z","timestamp":1787167313000},"page":"2153-2161","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Curative-Intent Cryoablation for Bone Metastases: Study Protocol for BOREALIS, a Prospective Multicentre Observational Investigation"],"prefix":"10.1007","volume":"49","author":[{"given":"Roberto Luigi","family":"Cazzato","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Buy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Gomez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederic","family":"Deschamps","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk","family":"Arnold","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitrios","family":"Filippiadis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jack","family":"Jennings","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niklaus","family":"Schaefer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Schneegans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgia","family":"Tsoumakidou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bleranda","family":"Zeka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1063-5830","authenticated-orcid":false,"given":"Claire","family":"Poulet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Kaufmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Palussiere","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Afshin","family":"Gangi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,8,19]]},"reference":[{"key":"4550_CR1","doi-asserted-by":"publisher","DOI":"10.1007\/s12032-016-0848-3","author":"RL Cazzato","year":"2016","unstructured":"Cazzato RL, Garnon J, Ramamurthy N, Koch G, Tsoumakidou G, Caudrelier J, et al. 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FD and JJ serve as consultants and medical advisors to Boston Scientific and other companies in oncology outside the submitted work. DA reports speaker fees from Boston Scientific and, outside the submitted work, speaker and advisory board fees from several companies in oncology, and holds leadership roles in relevant professional societies.","order":1,"name":"Ethics","label":"Conflicts of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"For this type of study, consent for publication is not required. However, consent for publication was obtained for every individual person\u2019s data included in the study.\n                      Ethical Approval.\n                      All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.","order":2,"name":"Ethics","label":"Consent to Publish","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","label":"Informed Consent","group":{"name":"EthicsHeading","label":"Declarations"}}]}}