A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases
Henry Ford Health System
Summary
The purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve quality of life. We will also assess how effective these combined modes of treatment are in patients with spinal metastasis with an epidural component.
Description
Primary Objectives: 1. Documenting rate of local control in patients who have received this combined treatment and 2. Documenting safety of MRI compatible hardware for MRI based image guidance 3. Determining the accuracy of the MRI-based image guidance Secondary Objectives: 1. To determine local control at 1, 3, 6, 9, 18, and 24 months, and to compare to a historical control where patients received only SSRS at these time points and at 12 months. 2. To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months * Calculate decrease in epidural tumor volume (by v…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \> 18 years old. (The indication for this technique is controversial in skeletally immature patients.) * Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors. * Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is en…
Interventions
- ProcedureStereotactic Laser Ablation
MR Guided laser ablation therapy
- RadiationStereotactic Radiosurgery
Precise delivery of radiation to spinal tumor
- Diagnostic TestMRI guided laser ablation
Surgery will take place in intraoperative suite to include operating room and MRI scanner
Location
- Henry Ford HospitalDetroit, Michigan