Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-06-30
2023-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ablation and Cementoplasty
All patients undergoing thermal ablation and cementoplasty procedure for one or more painful bone lesion
Ablation and Cementoplasty
Percutaneous thermal ablation with subsequent cementoplasty in a single procedure
Interventions
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Ablation and Cementoplasty
Percutaneous thermal ablation with subsequent cementoplasty in a single procedure
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Jason Wong
Interventional Radiologist; Clinical Associate Professor, University of Calgary
Principal Investigators
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Jason K Wong
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
South Health Campus
Calgary, Alberta, Canada
Countries
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Central Contacts
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Other Identifiers
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REB20-1593
Identifier Type: -
Identifier Source: org_study_id
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