Bipolar RFA of Painful Extra-spinal Bone Metastases (PERFACOOL)

  • End date
    Jul 25, 2024
  • participants needed
  • sponsor
    University Hospital, Strasbourg, France
Updated on 4 October 2022


To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system.

Condition Multi-metastatic Cancer
Treatment Percutaneous RFA
Clinical Study IdentifierNCT03738670
SponsorUniversity Hospital, Strasbourg, France
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

) Multi-metastatic cancer patients with at least one painful lytic bone metastasis
) Target lesion should correspond to a specific radiologic finding
) At least a moderate pain produce by target lesion (4 on a scale of 0 to 10 over the prior 24 hours with or without pain killers intake) assessed during selection evaluation
) Patients 18 years old
) Able to give written consent
) Life expectancy 1 months
) Patient affiliated to the National Health Insurance system

Exclusion Criteria

Radiation therapy on the target tumor terminated < 3 weeks before treatment
Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk
Any contra-indication for the procedure as stated by the radiologist related to patient's condition (e.g. cardiac pacemakers) making the procedure at unacceptable risk
Impaired haemostasis
Concurrent participation in other experimental studies that could affect endpoints of this study
Contraindication to any form of sedation/anaesthesia
Signs of local/systemic infection identified before procedure, in accordance with standard care
Sclerotic metastases
Adults under guardianship
Patients under judicial protection
Pregnant or breastfeeding woman
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