Bone LesionNCT04635137
Ablation and Cementoplasty for Painful Bone Lesions
A study testing Ablation and Cementoplasty in people with Bone Lesion and Bone Metastases, run by University of Calgary at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Lesion, Bone Metastases, Spine Metastases
- What is being tested?
- Ablation and Cementoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2021to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Stefan Przybojewski, MD
South Health Campus
Calgary, Alberta, T3M 1M4
Stefan Przybojewski, MD
About this study
Official title: Percutaneous Ablation and Cementoplasty for Painful Bone Lesions: A Canadian Single-Centre Experience
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.
Read the detailed description
Research Question \& Objectives
- To conduct a prospective, single-centre study of combined ablation and cementoplasty treatment for painful spinal and extraspinal osseous lesions.
- Report the technical outcome and safety of percutaneous ablation prior to image-guided cementoplasty in a single treatment session.
- 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.
- 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
- Bone Lesion, Bone Metastases, Spine Metastases
- Being tested
- Ablation and Cementoplasty
- Keywords
- Ablation, Cementoplasty, Pain Palliation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation and CementoplastyProcedure or surgery
Percutaneous thermal ablation with subsequent cementoplasty in a single procedure
| Study group | Role | What they receive |
|---|---|---|
| Ablation and Cementoplasty | Experimental | All patients undergoing thermal ablation and cementoplasty procedure for one or more painful bone lesion Receives: Procedure: Ablation and Cementoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Measured: Pre-procedure
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Measured: immediately post-procedure
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Measured: 1 week post-procedure
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Measured: 1 month post-procedure
Pain Scale
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months post-procedure
Analgesia
Opioid and non-opioid analgesia use
Measured: Pre-procedure
Analgesia
Opioid and non-opioid analgesia use
Measured: immediately post-procedure
Analgesia
Opioid and non-opioid analgesia use
Measured: 1 week post-procedure
Analgesia
Opioid and non-opioid analgesia use
Measured: 1 month post-procedure
Analgesia
Opioid and non-opioid analgesia use
Measured: 3 months post-procedure
Secondary outcomes (1)
Disease Burden
Tumor burden as assessed by CT scan following procedure as compared to pre-procedure scan
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study startJun 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LesionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective study of pain and quality of life before and after ablation/cementoplasty procedure
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Wong, University of Calgary
- Investigators
- Jason K Wong, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635137
- Sponsor's protocol ID
- REB20-1593
- Status last verified
- Apr 2021
- First submitted
- 9 Nov 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Ablation and Cementoplasty for Painful Bone Lesions: A Canadian Single-Centre Experience
- ClinicalTrials.gov ID
- NCT04635137
- Acronym / sponsor ID
- REB20-1593
- Conditions
- Bone Lesion, Bone Metastases, Spine Metastases
- Keywords
- Ablation, Cementoplasty, Pain Palliation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To conduct a prospective, single-centre study of combined ablation and cementoplasty treatment for painful spinal and extraspinal osseous lesions.
- Report the technical outcome and safety of percutaneous ablation prior to image-guided cementoplasty in a single treatment session.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm prospective study of pain and quality of life before and after ablation/cementoplasty procedure
| Arm | Type | Receives |
|---|---|---|
| Ablation and Cementoplasty | Experimental | Procedure: Ablation and CementoplastyAll patients undergoing thermal ablation and cementoplasty procedure for one or more painful bone lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- non-correctable coagulation disorder
- systemic or localized infection
- multiple painful lesions requiring different treatment approaches
- neurological deficits or radicular neurological symptoms
- rheumatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation and CementoplastyPercutaneous thermal ablation with subsequent cementoplasty in a single procedure | Procedure or surgery | Ablation and Cementoplasty |
Primary outcome
Pain Scale
Time frame: Pre-procedure
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Pain Scale
Time frame: immediately post-procedure
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Pain Scale
Time frame: 1 week post-procedure
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Pain Scale
Time frame: 1 month post-procedure
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Pain Scale
Time frame: 3 months post-procedure
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Quality of Life Questionnaire
Time frame: Pre-procedure
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.
Quality of Life Questionnaire
Time frame: immediately post-procedure
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.
Quality of Life Questionnaire
Time frame: 1 week post-procedure
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.
Quality of Life Questionnaire
Time frame: 1 month post-procedure
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.
Quality of Life Questionnaire
Time frame: 3 months post-procedure
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.
Analgesia
Time frame: Pre-procedure
Opioid and non-opioid analgesia use
Analgesia
Time frame: immediately post-procedure
Opioid and non-opioid analgesia use
Analgesia
Time frame: 1 week post-procedure
Opioid and non-opioid analgesia use
Analgesia
Time frame: 1 month post-procedure
Opioid and non-opioid analgesia use
Analgesia
Time frame: 3 months post-procedure
Opioid and non-opioid analgesia use
1 secondary outcome
Disease Burden
Time frame: 3 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason K Wong principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation and Cementoplasty in people with Bone Lesion and Bone Metastases, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason K Wong (403-944-4634, wongjk@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scale (time frame: Pre-procedure). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.