Spine MetastasesNCT05317026
Increased Early Pain Relief by Adding Vertebroplasty to SBRT
A study testing Vertebroplasty and Stereotactic Body Radiation Therapy only in people with Spine Metastases and Radiation Therapy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial summary
The goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Metastases, Radiation Therapy, Pain
- What is being tested?
- Vertebroplasty and Stereotactic Body Radiation Therapy only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 22 Nov 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Histological evidence of cancer.
- Spinal and vertebral bone metastases (T5 to L5) documented by imaging.
- Pain related to metastases ≥ 4 on a numerical scale 0-10.
- Karnofsky performance index > 60 (ecog 0-2)
- Candidate for SBRT
- Less than 3 consecutive levels reached.
- Ability to complete follow-up questionnaires regarding pain, analgesics, and quality of life assessment.
- Potentially unstable lesions according to the spinal instability neoplastic score (SINS) scale (> or = 7)
Who cannot join
- Pregnancy or breastfeeding.
- Contraindications to MRI.
- Histology: myeloma, lymphoma or plasmacytoma.
- Radiotherapy prior to the level to be treated.
- Previous surgery at the site to be treated.
- Surgical indication:
Show all 14Show fewer
- spinal instability neoplastic score (SINS) > 13 or according to tumor board consensus.
- Bilsky score > or = 2 Severe or progressive neurological signs (motor, incontinence).
- Lesion too large for safe vertebroplasty.
- High thoracic location not allowing safe visibility in fluoroscopy to perform vertebroplasty (T4 and above).
- Non-reversible coagulation disorders.
- Uncontrolled local or systemic infection.
- Estimated survival of less than 6 months.
- Inability or refusal to undergo SBRT treatment or vertebroplasty
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
CHUM
Montreal, Quebec, H2X0C1
Veronique Freire, MD, 514-883-6154, veronique.freire.med@ssss.gouv.qc.ca
Mom PHAT, 514 890-8000 ext. 11171
- Recruiting
Véronique Freire
Montreal, Quebec
Véronique Freire, MD
Laura Masucci, MD
About this study
Official title: Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief
The goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain.
- Conditions
- Spine Metastases, Radiation Therapy, Pain
- Being tested
- Vertebroplasty, Stereotactic Body Radiation Therapy only
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertebroplastyProcedure or surgery
SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume.
The vertebroplasty will be performed according to the usual procedure at the center in the angiography suite under local anesthesia and conscious sedation
- Introduction of a vertebral needle, under biplanar fluoroscopic guidance, polymethylmethacrylate (PMMA) cement injection.
- Cone-beam volume-CT at the end of the procedure, with the angiography table and c-arm, to evaluate the cement distribution and detect any leak.
- Decubitus position for 2 hours following procedure, then hospital discharge on the same day.
Stereotactic Body Radiation Therapy onlyProcedure or surgery
Also called SBRT
SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume
| Study group | Role | What they receive |
|---|---|---|
| V-SBRT | Experimental | Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT) Receives: Procedure: Vertebroplasty |
| SBRT | Other | SBRT is the actual standard of care. Receives: Procedure: Stereotactic Body Radiation Therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain change at 1 month
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
Measured: 1 month following the treatment
Secondary outcomes (5)
Pain change
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
Measured: 1 week, 1 month, 3 months and 6 months post treatment
Change in level of physical, psychological and social functions
EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life)
Measured: at 1 week, 1 month, 3 months and 6 months post treatment
Change in symptoms related to bone metastasis
QLQ-Bone metastases : BM22 questionnaire (All of the scales range in score from 0 to 100. A high score for the symptom scales represents a high level of symptomatology or problems, whilst a high score for the functional scales represents a high level of functioning)
Measured: at 1 week, 1 month, 3 months and 6 months post treatment
Change in performance for activities of daily living
Karnofsky performance scale (score from 0 to 100, the lower the Karnofsky score, themore disable the patient is and need assistance)
Measured: at 1 week, 1 month, 3 months and 6 months post treatment
Post-treatment fracture rates
evaluation by MRI +/- CT imaging
Measured: at 3, 6, 12 and 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start22 Nov 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spine MetastasesStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Freire, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317026
- Sponsor's protocol ID
- 2022-10542
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0.
PubMed 42032732
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief
- ClinicalTrials.gov ID
- NCT05317026
- Acronym / sponsor ID
- 2022-10542
- Conditions
- Spine Metastases, Radiation Therapy, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Apr 2022 (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 goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V-SBRT | Experimental | Procedure: VertebroplastyVertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT) |
| SBRT | Other | Procedure: Stereotactic Body Radiation Therapy onlySBRT is the actual standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological evidence of cancer.
- Spinal and vertebral bone metastases (T5 to L5) documented by imaging.
- Pain related to metastases ≥ 4 on a numerical scale 0-10.
- Karnofsky performance index > 60 (ecog 0-2)
- Candidate for SBRT
Key exclusion criteria (14 listed)
- Pregnancy or breastfeeding.
- Contraindications to MRI.
- Histology: myeloma, lymphoma or plasmacytoma.
- Radiotherapy prior to the level to be treated.
- Previous surgery at the site to be treated.
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 |
|---|---|---|
| VertebroplastySBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume. The vertebroplasty will be performed according to the usual procedure at the center in the angiography suite under local anesthesia and conscious sedation * Introduction of a vertebral needle, under biplanar fluoroscopic guidance, polymethylmethacrylate (PMMA) cement injection. * Cone-beam volume-CT at the end of the procedure, with the angiography table and c-arm, to evaluate the cement distribution and detect any leak. * Decubitus position for 2 hours following procedure, then hospital discharge on the same day. | Procedure or surgery | V-SBRT |
| Stereotactic Body Radiation Therapy onlyAlso: SBRTSBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume | Procedure or surgery | SBRT |
Primary outcome
Pain change at 1 month
Time frame: 1 month following the treatment
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
5 secondary outcomes
Pain change
Time frame: 1 week, 1 month, 3 months and 6 months post treatment
Change in level of physical, psychological and social functions
Time frame: at 1 week, 1 month, 3 months and 6 months post treatment
Change in symptoms related to bone metastasis
Time frame: at 1 week, 1 month, 3 months and 6 months post treatment
Change in performance for activities of daily living
Time frame: at 1 week, 1 month, 3 months and 6 months post treatment
Post-treatment fracture rates
Time frame: at 3, 6, 12 and 24 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Derived from this study: PubMed 42032732Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0.
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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.
Véronique Freire, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertebroplasty and Stereotactic Body Radiation Therapy only in people with Spine Metastases and Radiation Therapy, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Véronique Freire, MD (514-890-8000, veronique.freire.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain change at 1 month (time frame: 1 month following the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05317026, which also lists 1 linked publication.
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 24 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.