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New treatment option for Spine Metastases
Official title Increased Early Pain Relief by Adding Vertebroplasty to SBRT
ClinicalTrials.gov ID: NCT05317026
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.