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.
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 volumetric measurements using Brain Lab Elements software) * Calculate increase in thecal sac patency (by volumetric measurements using Brain Lab Elements software and according to Bilsky method 3. To determine overall survival at 6, 12, 18, and 24 months. 4. To assess changes in muscle strength, location and severity of spinal-related pain, sensory function, ability to ambulate, and neurological grading at 1, 3, 6, 9, 12, 18, and 24 months compared with pretreatment baselines. 5. To assess the effect of treatment on quality of life, measured at 1 month and every 3 months after with validated outcome measure tools 6. To describe adverse side effects after treatment and to descriptively correlate those effects with radiographic findings, pain control, and quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
MR Guided laser ablation therapy
Precise delivery of radiation to spinal tumor
Surgery will take place in intraoperative suite to include operating room and MRI scanner
Henry Ford Hospital
Detroit, Michigan, United States
RECRUITINGLocal Tumor Control Rate
Kaplan-Meier estimates will be used.
Time frame: up to 24 months
Local Tumor Control
Time to local failure will be monitored continuously using Bayesian method.
Time frame: 1, 3, 6, 9, 12, 18, and 24 months
Postoperative response to treatment assessed by MRI
Routine MRI of the spine with and without contrast will be obtained at each follow-up visit. These post-treatment scans will be analyzed and compared to baseline scans for assessment of treatment response and local control. Bilsky grading system will be used.
Time frame: 1, 3, 6, 9, 12, 18, and 24 months
Adverse Events
To describe adverse side effects after treatment and descriptively correlate those effects with radiographic findings, pain control, and quality of life.
Time frame: up to 24 months
Overall Survival
Kaplan-Meier estimates will be used.
Time frame: 6, 12, 18, and 24 months
Changes in symptoms assessed by physical examination
The Physical Exam includes a general exam:(HEENT) Head, Eye, Ear, Nose and Throat evaluation, chest, heart, abdomen and extremities exam. Changes will be compared to baseline measurements. Negative changes will be evaluated by the neurosurgeon and radiation oncologist to determine if the change is related to a local failure or progression of systemic disease. Kaplan-Meier estimates will be used.
Time frame: 1, 3, 6, 9, 12, 18, 24 months and annually thereafter
Changes in symptoms assessed by neurological examination
The neurological examination includes: mental status (tested through history taking), cranial nerves (observation of eyes, face, voice, and coordination during history taking and as patient moves about the exam room), motor system (visual inspection, tone, muscle strength and endurance, assigned score of 0-5 for each muscle, a score of 0 would mean no muscular contraction, and a score of 5 would mean movement against full resistance, normal strength), reflexes, sensory system (vibration in toes; pinprick in feet); coordination (truncal stability, fine finger movement, toe tapping, finger-nose-finger, heel-knee-shin), and station and gait (gait including arising from chair without hands, walking on toes, heels, and heel to toe). Kaplan-Meier estimates will be used.
Time frame: 1, 3, 6, 9, 12, 18, and 24 months
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