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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Percutaneous thermal ablation with subsequent cementoplasty in a single procedure
Foothills Medical Centre
Calgary, Alberta, Canada
South Health Campus
Calgary, Alberta, Canada
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Time frame: Pre-procedure
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Time frame: immediately post-procedure
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Time frame: 1 week post-procedure
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Time frame: 1 month post-procedure
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months post-procedure
Analgesia
Opioid and non-opioid analgesia use
Time frame: Pre-procedure
Analgesia
Opioid and non-opioid analgesia use
Time frame: immediately post-procedure
Analgesia
Opioid and non-opioid analgesia use
Time frame: 1 week post-procedure
Analgesia
Opioid and non-opioid analgesia use
Time frame: 1 month post-procedure
Analgesia
Opioid and non-opioid analgesia use
Time frame: 3 months post-procedure
Disease Burden
Tumor burden as assessed by CT scan following procedure as compared to pre-procedure scan
Time frame: 3 months post-procedure
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