Increased Early Pain Relief by Adding Vertebroplasty to SBRT
Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief
Centre hospitalier de l'Université de Montréal (CHUM)
50 participants
Nov 22, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria14
- 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
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Interventions
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.
SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume
Locations(2)
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NCT05317026