Actively Recruiting
Increased Early Pain Relief by Adding Vertebroplasty to SBRT
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-08-07
50
Participants Needed
2
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Increased Early Pain Relief by Adding Vertebroplasty to SBRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological evidence of cancer
- Spinal and vertebral bone metastases from T5 to L5 documented by imaging
- Pain related to metastases of 4 or higher on a 0-10 scale
- Karnofsky performance index greater than 60 (ECOG 0-2)
- Candidate for stereotactic body radiation therapy (SBRT)
- Less than 3 consecutive vertebral levels affected
- Ability to complete follow-up questionnaires on pain, medication, and quality of life
- Potentially unstable lesions with spinal instability neoplastic score (SINS) of 7 or higher
You will not qualify if you...
- Pregnancy or breastfeeding
- Contraindications to MRI
- Diagnosis of myeloma, lymphoma, or plasmacytoma
- Previous radiotherapy at the treatment site
- Previous surgery at the treatment site
- Surgical indication with SINS score above 13 or tumor board consensus
- Bilsky score 2 or higher, or severe/progressive neurological symptoms
- Lesion too large for safe vertebroplasty
- Lesion located above T4, preventing safe fluoroscopic visibility
- Non-reversible blood clotting disorders
- Uncontrolled local or systemic infection
- Expected survival less than 6 months
- Inability or refusal to undergo SBRT or vertebroplasty treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
CHUM
Montreal, Quebec, Canada, H2X0C1
Actively Recruiting
2
Véronique Freire
Montreal, Quebec, Canada
Actively Recruiting
Research Team
V
Véronique Freire, MD
CONTACT
F
Fidaa Al-Shakfa, M.sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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