Ablation and Cementoplasty for Painful Bone Lesions

Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04635137
• Other study ID #: REB20-1593
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: March 2023

Study information

• Verified date: April 2021
• Source: University of Calgary
• Contact: Jason K Wong
• Phone: 403-944-4634
• Email: wongjk[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Lesion
• Bone Metastases
• Neoplasm Metastasis
• Spine Metastases

Intervention

Procedure:
• Ablation and Cementoplasty
Percutaneous thermal ablation with subsequent cementoplasty in a single procedure

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	South Health Campus	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	Pre-procedure
Primary	Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	immediately post-procedure
Primary	Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	1 week post-procedure
Primary	Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	1 month post-procedure
Primary	Pain Scale	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.	3 months post-procedure
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Analgesia	Opioid and non-opioid analgesia use	Pre-procedure
Primary	Analgesia	Opioid and non-opioid analgesia use	immediately post-procedure
Primary	Analgesia	Opioid and non-opioid analgesia use	1 week post-procedure
Primary	Analgesia	Opioid and non-opioid analgesia use	1 month post-procedure
Primary	Analgesia	Opioid and non-opioid analgesia use	3 months post-procedure
Secondary	Disease Burden	Tumor burden as assessed by CT scan following procedure as compared to pre-procedure scan	3 months post-procedure