NCT05317026 Increased Early Pain Relief by Adding Vertebroplasty to SBRT
| NCT ID | NCT05317026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Spine Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-11-22 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-11-22 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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: 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 locatio
Frequently Asked Questions
Who can join the NCT05317026 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spine Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05317026 currently recruiting?
Yes, NCT05317026 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre hospitalier de l'Université de Montréal (CHUM) to inquire about joining.
Where is the NCT05317026 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT05317026 clinical trial?
NCT05317026 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 50 participants.