Recruiting

Vertebroplasty & SBRT

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05317026

Conditions

Spine Metastases

Radiation Therapy

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vertebroplasty

Stereotactic Body Radiation Therapy only

Study Details

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.

Conditions

Spine Metastases

Radiation Therapy

Pain

Study ID

NCT05317026

Start date

Nov 22, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: V-SBRT

Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)

other: SBRT

SBRT is the actual standard of care.

Interventions

Vertebroplasty

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

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

Primary outcome measure

  • Pain change at 1 month [ Time Frame: 1 month following the treatment ]

Central Contacts and Locations

Central contacts

Véronique Freire, MD

514-890-8000veronique.freire.med@ssss.gouv.qc.ca

Fidaa Al-Shakfa, M.sc.

514-890-8000f.alshakfa.crchum@gmail.com

Locations

CHUM

Recruiting

Montreal, Quebec, Canada, H2X0C1

Contacts

Veronique Freire, MD

514-883-6154veronique.freire.med@ssss.gouv.qc.ca

Mom PHAT

514 890-8000

Véronique Freire

Recruiting

Montreal, Quebec, Canada

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-08-24.