Cryoablation system
DeviceAny cryoablation system from Boston Scientific that has received CE Mark and/or FDA clearance for the ablation of bone malignancies.
NCT Number: NCT06480955
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Institute Bergonié, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Any cryoablation system from Boston Scientific that has received CE Mark and/or FDA clearance for the ablation of bone malignancies.
Time frame: 12 months
On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate
Time frame: Periprocedurally
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: Through study completion
Incidence and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 12 months
On a per lesion basis, proportion of target lesions with complete response status
Time frame: End of study
On a per lesion basis,time between cryoablation and fracture at treated site
Time frame: Until the end of the follow-up period (1 year)
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)
Time between cryoablation and progression in the bone (incl. new lesions)
Time frame: Until the end of the follow-up period (1 year)
Time between cryoablation and extra-osseous progression (incl. new lesions)
Time frame: Until the end of the follow-up period (1 year)
Time between cryoablation and any progression (incl. new lesions) or death
Time frame: Until the end of the follow-up period (1 year)
Time between cryoablation and death
Time frame: Until the end of the follow-up period (1 year)
Time between cryoablation and the next systemic treatment (excluding any adjuvant treatment that was part of the patient's treatment plan)
Time frame: 1, 3, 6, 12 months
Patient-reported pain assessment using the Brief Pain Inventory - short form
Time frame: 1, 3, 6, 12 months
Patient-reported quality of life assessment using the EORTC QLQ-C30 questionnaire
Contact information is provided by the study sponsor or research team.
Claire E Poulet, PhD
CONTACT
Dhwani S. Korde, PhD
CONTACT
Cardiovascular and Interventional Radiological Society of Europe
Other
Acronym: BOREALIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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