RECRUITING Not applicable ClinicalTrials.gov

Increased Early Pain Relief by Adding Vertebroplasty to SBRT

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) • ClinicalTrials.gov ID: NCT05317026

Registry updated: 2026-08-24

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Description

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.

Interventions

Vertebroplasty (Procedure)
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 only (Procedure)
SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume

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 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

Conditions

Spine Metastases Radiation Therapy Pain

Locations

CHUM — Montreal, Quebec, Canada
Véronique Freire — Montreal, Quebec, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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