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

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

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.

Study Overview

• Status: Terminated
• Conditions: Multi-metastatic Cancer
• Intervention / Treatment: Procedure: Percutaneous RFA

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • University Hospital, Strasbourg, france

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Luigi Roberto CAZZATO, MD, University Hospital, Strasbourg, france

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): December 2, 2021
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Bone metastases; Radiofrequency ablation; RFA; Extra-spinal
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 7010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No