Ablation and Cementoplasty for Painful Bone Lesions

NCT04635137 | Unknown

• 1 other identifier: REB20-1593
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Lesion; Bone Metastases; Spine Metastases

Keywords

Ablation; Cementoplasty; Pain Palliation

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (1)

• Disease Burden

  3 months post-procedure

Study Arms (1)

Ablation and Cementoplasty

EXPERIMENTAL

All patients undergoing thermal ablation and cementoplasty procedure for one or more painful bone lesion

Procedure: Ablation and Cementoplasty

Interventions

Ablation and Cementoplasty PROCEDURE

Percutaneous thermal ablation with subsequent cementoplasty in a single procedure

Ablation and Cementoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

MeSH Terms

Interventions

Cementoplasty

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jason K Wong

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason K Wong

CONTACT

403-944-4634; wongjk@ucalgary.ca

Stefan Przybojewski

CONTACT

403-944-4634; stefan.przybojewski@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Radiologist; Clinical Associate Professor, University of Calgary

Model Details: Single-arm prospective study of pain and quality of life before and after ablation/cementoplasty procedure

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 18, 2020
• Study Start: June 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)