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

Primary Purpose

Multi-metastatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Percutaneous RFA
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multi-metastatic Cancer focused on measuring Pain, Extra-spinal, RFA, Radiofrequency ablation, Bone metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital, Strasbourg, franceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RFA

Arm Description

Single-arm prospective observational study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Safety will be assessed according to SIR(11) / CTCAE classification
Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up.
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.

Full Information

First Posted
November 5, 2018
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03738670
Brief Title
Bipolar RFA of Painful Extra-spinal Bone Metastases
Acronym
PERFACOOL
Official Title
Pain Evaluation After Treatment of Extra-spinal Bone Metastases With OsteoCOOL Radiofrequency (RF) Ablation System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi-metastatic Cancer
Keywords
Pain, Extra-spinal, RFA, Radiofrequency ablation, Bone metastases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFA
Arm Type
Experimental
Arm Description
Single-arm prospective observational study
Intervention Type
Procedure
Intervention Name(s)
Percutaneous RFA
Intervention Description
Single session percutaneous extra-spinal bone metastasis destruction to achieve pain relief
Primary Outcome Measure Information:
Title
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
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
Time Frame
6 months
Title
Safety will be assessed according to SIR(11) / CTCAE classification
Time Frame
6 months
Title
Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up.
Time Frame
6 months
Title
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Roberto CAZZATO, MD
Phone
3 69 55 16 35
Ext
0033
Email
robertoluigi.cazzato@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Roberto CAZZATO, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Strasbourg, france
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Roberto CAZZATO, MD
Phone
3 69 55 16 35
Ext
0033
Email
robertoluigi.cazzato@chru-strasbourg.fr

12. IPD Sharing Statement

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Bipolar RFA of Painful Extra-spinal Bone Metastases

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