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Ablation and Cementoplasty for Painful Bone Lesions

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ClinicalTrials.gov Identifier: NCT04635137
Recruitment Status : Not yet recruiting
First Posted : November 18, 2020
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Jason Wong, University of Calgary

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Bone Lesion Bone Metastases Spine Metastases Procedure: Ablation and Cementoplasty Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm prospective study of pain and quality of life before and after ablation/cementoplasty procedure
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Ablation and Cementoplasty for Painful Bone Lesions: A Canadian Single-Centre Experience
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pain Scale [ Time Frame: Pre-procedure ]
    Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.

  2. Pain Scale [ Time Frame: immediately post-procedure ]
    Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.

  3. Pain Scale [ Time Frame: 1 week post-procedure ]
    Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.

  4. Pain Scale [ Time Frame: 1 month post-procedure ]
    Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.

  5. Pain Scale [ Time Frame: 3 months post-procedure ]
    Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.

  6. Quality of Life Questionnaire [ Time Frame: Pre-procedure ]
    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.

  7. Quality of Life Questionnaire [ Time Frame: immediately post-procedure ]
    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.

  8. Quality of Life Questionnaire [ Time Frame: 1 week post-procedure ]
    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.

  9. Quality of Life Questionnaire [ Time Frame: 1 month post-procedure ]
    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.

  10. Quality of Life Questionnaire [ Time Frame: 3 months post-procedure ]
    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.

  11. Analgesia [ Time Frame: Pre-procedure ]
    Opioid and non-opioid analgesia use

  12. Analgesia [ Time Frame: immediately post-procedure ]
    Opioid and non-opioid analgesia use

  13. Analgesia [ Time Frame: 1 week post-procedure ]
    Opioid and non-opioid analgesia use

  14. Analgesia [ Time Frame: 1 month post-procedure ]
    Opioid and non-opioid analgesia use

  15. Analgesia [ Time Frame: 3 months post-procedure ]
    Opioid and non-opioid analgesia use


Secondary Outcome Measures :
  1. Disease Burden [ Time Frame: 3 months post-procedure ]
    Tumor burden as assessed by CT scan following procedure as compared to pre-procedure scan


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635137


Contacts
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Contact: Jason K Wong 403-944-4634 wongjk@ucalgary.ca
Contact: Stefan Przybojewski 403-944-4634 stefan.przybojewski@albertahealthservices.ca

Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Sub-Investigator: Stefan Przybojewski, MD         
South Health Campus
Calgary, Alberta, Canada, T3M 1M4
Principal Investigator: Stefan Przybojewski, MD         
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Jason K Wong University of Calgary
More Information
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Responsible Party: Jason Wong, Interventional Radiologist; Clinical Associate Professor, University of Calgary, University of Calgary
ClinicalTrials.gov Identifier: NCT04635137    
Other Study ID Numbers: REB20-1593
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Wong, University of Calgary:
Ablation
Cementoplasty
Pain Palliation
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes