Clinical trial NCT04635137: Ablation and Cementoplasty for Painful Bone Lesions
Official title: Percutaneous Ablation and Cementoplasty for Painful Bone Lesions: A Canadian Single-Centre Experience
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Lesion
Bone Metastases
Spine Metastases
Keywords: Ablation
Cementoplasty
Pain Palliation
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm prospective study of pain and quality of life before and after ablation/cementoplasty procedure
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain Scale
timeFrame: Pre-procedure
measure: Pain Scale
timeFrame: immediately post-procedure
measure: Pain Scale
timeFrame: 1 week post-procedure
measure: Pain Scale
timeFrame: 1 month post-procedure
measure: Pain Scale
timeFrame: 3 months post-procedure
measure: Quality of Life Questionnaire
timeFrame: Pre-procedure
measure: Quality of Life Questionnaire
timeFrame: immediately post-procedure
measure: Quality of Life Questionnaire
timeFrame: 1 week post-procedure
measure: Quality of Life Questionnaire
timeFrame: 1 month post-procedure
measure: Quality of Life Questionnaire
timeFrame: 3 months post-procedure
measure: Analgesia
timeFrame: Pre-procedure
measure: Analgesia
timeFrame: immediately post-procedure
measure: Analgesia
timeFrame: 1 week post-procedure
measure: Analgesia
timeFrame: 1 month post-procedure
measure: Analgesia
timeFrame: 3 months post-procedure
Secondary outcomes:
measure: Disease Burden
timeFrame: 3 months post-procedure
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jason K Wong
role: PRINCIPAL_INVESTIGATOR
References: