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

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Multi-metastatic Cancer

Treatments: Procedure: Percutaneous RFA

Study type: Interventional

Funder types: Other

Identifiers

NCT03738670

7010

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. Radiation therapy on the target tumor terminated < 3 weeks before treatment
2. 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
3. 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
4. Impaired haemostasis
5. Concurrent participation in other experimental studies that could affect endpoints of this study
6. Contraindication to any form of sedation/anaesthesia
7. Signs of local/systemic infection identified before procedure, in accordance with standard care
8. Sclerotic metastases
9. Adults under guardianship
10. Patients under judicial protection
11. Pregnant or breastfeeding woman

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

RFA

Experimental group

Description:

Single-arm prospective observational study

Treatment:

Procedure: Percutaneous RFA