Bipolar RFA of Painful Extra-spinal Bone Metastases

Study Overview
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Brief Summary
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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.

Official Title
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Pain Evaluation After Treatment of Extra-spinal Bone Metastases With OsteoCOOL Radiofrequency (RF) Ablation System

Conditions
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Multi-metastatic Cancer

Intervention / Treatment
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* Procedure: Percutaneous RFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Multi-metastatic cancer patients with at least one painful lytic bone metastasis 2) Target lesion should correspond to a specific radiologic finding 3) 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 4) Patients 18 years old 5) Able to give written consent 6) Life expectancy 1 months 7) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA<br>Single-arm prospective observational study | Procedure: Percutaneous RFA<br>* Single session percutaneous extra-spinal bone metastasis destruction to achieve pain relief<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of responding patients reporting an improvement of at least 3 points on item 3 the worst pain in the last 24 hours of Brief Pain Inventory (BPI) questionnaire |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the mean scores of the items 3, 5, 9B and 8 of the BPI questionnaire between the baseline and 6-month follow-up |  | 6 months | 
| Safety will be assessed according to SIR(11) / CTCAE classification |  | 6 months | 
| Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up. |  | 6 months | 
| Percentage of responding patients defined by an improvement of at least 3 points on item 3 the worst pain in the last 24 hours of Brief Pain Inventory (BPI) questionnaire at 3 and 6 month follow-up. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Extra-spinal, RFA, Radiofrequency ablation, Bone metastases