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The objective of this clinical study is to evaluate the efficacy and safety of spinal laser interstitial therapy in the treatment of metastatic spinal tumors. The investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Laser Interstitial Thermal Therapy (sLITT) | Experimental | Patients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearPoint Prism | Device | Spine laser interstitial therapy used instead of open decompression followed by spine stereotactic radiosurgery (SSRS). |
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| Measure | Description | Time Frame |
|---|---|---|
| Local tumor control | Any increase in the epidural spinal cord compression score (ESCC grade 1 (no compression) to 3 (spinal cord compression) compared to the initial post-procedure MRI will be considered local radiographic failure or evidence of tumor recurrence. | Local control rate at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate neurologic function before and after sLITT. | Using Frankel score. Frankel scores (scale form A to E where A= complete loss of motor and sensory function, B= complete motor paralysis but some sensory function, C= some motor function but not usable, D= weakened but usable motor function, E= neurologically intact) | 3, 6, 9, and 12 months post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Sinks, MPH | Contact | 603-650-6380 | lauren.j.sinks@hitchcock.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Health | Recruiting | Lebanon | New Hampshire | 03766 | United States |
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