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New treatment option for Spinal Cord
Official title Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
ClinicalTrials.gov ID: NCT06204315
What this study is testing
- What it's testing
- To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.
- Phase 2: a mid-size study of how well it works
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
- Greater than or equal to 18 years old
- Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration
- Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI
- All participants must be able to receive single fraction SSRS at the site of interest with 0.01 cc of the spinal cord receiving 14-16 Gy and/or 0.01...
- Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
You likely can't join if
- Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma/plasmacytoma)
- Prior history of radiation at the spinal site of interest
- Inability to lie supine comfortably for ≥ 60 minutes
- Progressive neurological deficits due to compression
- Inability of obtain an MRI
- Inability or refusal to undergo an MR simulation
See the full eligibility criteria
- Greater than or equal to 18 years old
- Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration
- Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI
- All participants must be able to receive single fraction SSRS at the site of interest with 0.01 cc of the spinal cord receiving 14-16 Gy and/or 0.01 cc of the cauda equina receiving 18-20 Gy. The goal of treatment is to...
- Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
- All participants must be able to receive a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gy
- All participants must have a vertebral level site of interest from C1 to S2
- Signed informed consent
- Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2)
- Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression
- ECOG ≤ 2
- Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma/plasmacytoma)
- Prior history of radiation at the spinal site of interest
- Inability to lie supine comfortably for ≥ 60 minutes
- Progressive neurological deficits due to compression
- Inability of obtain an MRI
- Inability or refusal to undergo an MR simulation
- No eligible for single fraction SSRS for any reason
- Participants who are pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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 Houston, Texas, United States. 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.