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Ablation and Cementoplasty for Painful Bone Lesions

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04635137
Enrollment
50
Registered
2020-11-18
Start date
2021-06-30
Completion date
2023-03-31
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Lesion, Bone Metastases, Spine Metastases

Keywords

Ablation, Cementoplasty, Pain Palliation

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.

Interventions

PROCEDUREAblation and Cementoplasty

Percutaneous thermal ablation with subsequent cementoplasty in a single procedure

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain ScalePre-procedureVisual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Quality of Life QuestionnairePre-procedureEuropean 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.
AnalgesiaPre-procedureOpioid and non-opioid analgesia use

Secondary

MeasureTime frameDescription
Disease Burden3 months post-procedureTumor burden as assessed by CT scan following procedure as compared to pre-procedure scan

Countries

Canada

Contacts

Primary ContactJason K Wong
wongjk@ucalgary.ca403-944-4634
Backup ContactStefan Przybojewski
stefan.przybojewski@albertahealthservices.ca403-944-4634

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026