Ablation and Cementoplasty for Painful Bone Lesions

Percutaneous Ablation and Cementoplasty for Painful Bone Lesions: A Canadian Single-Centre Experience

The aim of this research study is to assess the effectiveness of combined ablation and cementoplasty in the treatment of spinal, pelvic, and extraspinal lesions causing pain resistant to conventional treatment at our centre. In particular, the investigator seek to verify the safety and efficacy for multiple primary tumor types and benign lesions as well as encompass multiple measurements of outcome, including visual analog scale (VAS) for pain, opioid and analgesic use, and overall performance scales, combined with cross-sectional imaging follow-up to assess tumor burden, to ascertain a comprehensive Canadian single-centre experience that has been lacking in previous studies.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Metastases; Spine Metastases; Bone Lesion
• Intervention / Treatment: Procedure: Ablation and Cementoplasty

Detailed Description

Research Question & Objectives

1. To conduct a prospective, single-centre study of combined ablation and cementoplasty treatment for painful spinal and extraspinal osseous lesions.
2. Report the technical outcome and safety of percutaneous ablation prior to image-guided cementoplasty in a single treatment session.
3. Review the effectiveness and durability of pain control, local tumor control, and the impact on QoL using ablation and cementoplasty in treating spinal/extraspinal osseous tumors.
4. Assess the feasibility and efficacy of ablation and cementoplasty treatment for different primary tumor types and benign lesions.

Research Design

The investigators will conduct a single-centre, single-arm, cohort analysis of all patients who undergo cementoplasty for osseous disease in the department of interventional radiology over a two-year period. This will be a prospective paired comparison study with patients serving as their own controls. Technical success and procedural complications will be monitored and recorded for all patients. All patients will be followed until death or 3 months post-procedure.

The investigators aim to enroll a minimum of 40 patients referred for symptomatic osseous lesions. Bipolar radiofrequency ablation (Osteocool RFA system, Medtronic) or cryoablation (Visual Ice Cryoablation, Boston Scientific) will be performed under CT, ultrasound, or fluoroscopic guidance at the discretion of the treating radiologist, and immediately followed by cement injection. Radiological outcomes, including local tumor control and disease progression, will be assessed by CT imaging immediately post-procedure as well as 3-month follow-up. Clinical outcomes will be evaluated by VAS, analgesic use, and QoL assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) prior to procedure and immediately post-procedure, as well at 1-week, 1-month, and 3-month intervals post-procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason K Wong; Phone Number: 403-944-4634; Email: wongjk@ucalgary.ca
• Study Contact Backup: Name: Stefan Przybojewski; Phone Number: 403-944-4634; Email: stefan.przybojewski@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
      • Sub-Investigator: Stefan Przybojewski, MD
    • Calgary, Alberta, Canada, T3M 1M4
      • South Health Campus
      • Principal Investigator: Stefan Przybojewski, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• adult patient with spinal, pelvic, or extraspinal bone lesion
• pain clinically localized to a single region and tumor involvement confirmed with imaging
• life expectancy greater than 3 months
• provision of informed consent

Exclusion Criteria:

• non-correctable coagulation disorder
• systemic or localized infection
• multiple painful lesions requiring different treatment approaches
• neurological deficits or radicular neurological symptoms
• rheumatic disease
• pregnancy
• previous ablation and/or cementoplasty treatment to same lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Ablation and Cementoplasty; All patients undergoing thermal ablation and cementoplasty procedure for one or more painful bone lesion	Procedure: Ablation and Cementoplasty; Percutaneous thermal ablation with subsequent cementoplasty in a single procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	Pre-procedure
Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	immediately post-procedure
Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	1 week post-procedure
Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	1 month post-procedure
Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	3 months post-procedure
Quality of Life Questionnaire	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of 3 multi-item scales including a functional scale, a global health status/quality of life scale, and a symptom scale. Each scale ranges in score from 0-100 with a higher scale score representing a high/healthy level of functioning, quality of life, and symptomatology/problems, respectively.	Pre-procedure
Quality of Life Questionnaire	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of 3 multi-item scales including a functional scale, a global health status/quality of life scale, and a symptom scale. Each scale ranges in score from 0-100 with a higher scale score representing a high/healthy level of functioning, quality of life, and symptomatology/problems, respectively.	immediately post-procedure
Quality of Life Questionnaire	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of 3 multi-item scales including a functional scale, a global health status/quality of life scale, and a symptom scale. Each scale ranges in score from 0-100 with a higher scale score representing a high/healthy level of functioning, quality of life, and symptomatology/problems, respectively.	1 week post-procedure
Quality of Life Questionnaire	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of 3 multi-item scales including a functional scale, a global health status/quality of life scale, and a symptom scale. Each scale ranges in score from 0-100 with a higher scale score representing a high/healthy level of functioning, quality of life, and symptomatology/problems, respectively.	1 month post-procedure
Quality of Life Questionnaire	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of 3 multi-item scales including a functional scale, a global health status/quality of life scale, and a symptom scale. Each scale ranges in score from 0-100 with a higher scale score representing a high/healthy level of functioning, quality of life, and symptomatology/problems, respectively.	3 months post-procedure
Analgesia	Opioid and non-opioid analgesia use	Pre-procedure
Analgesia	Opioid and non-opioid analgesia use	immediately post-procedure
Analgesia	Opioid and non-opioid analgesia use	1 week post-procedure
Analgesia	Opioid and non-opioid analgesia use	1 month post-procedure
Analgesia	Opioid and non-opioid analgesia use	3 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Burden	Tumor burden as assessed by CT scan following procedure as compared to pre-procedure scan	3 months post-procedure

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Jason K Wong, University of Calgary

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Ablation; Pain Palliation; Cementoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: REB20-1593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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