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.
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
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 encouraged but not required.
The vertebral body site to be treated must be located from T2 to L1
No more than 3 contiguous or dis-contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.
Motor strength ≥4 out of 5 in extremity or extremities affected by the level of the spinal cord compression (see section 4 for grading method).
Single group
Stereotactic Laser Ablation
Procedure/SurgeryMR Guided laser ablation therapy
Stereotactic Radiosurgery
RadiationPrecise delivery of radiation to spinal tumor
MRI guided laser ablation
Diagnostic testSurgery will take place in intraoperative suite to include operating room and MRI scanner
Local Tumor Control Rate
Kaplan-Meier estimates will be used.
Local Tumor Control
Time to local failure will be monitored continuously using Bayesian method.
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.
Adverse Events
To describe adverse side effects after treatment and descriptively correlate those effects with radiographic findings, pain control, and quality of life.
Overall Survival
Kaplan-Meier estimates will be used.
Measuring Quality of life (QOL) assessed by Spine Tumor Survey (MDASI-SP)
We are measuring quality of life with the Spine Tumor Survey that will be assessed during each follow up Clinic visit. The patient survey will be assessed to measure postoperative response to treatment.
Measuring Quality of life (QOL) assessed by Health Survey (SF-36)
We are measuring quality of life with the Health Survey that will be assessed during each follow up Clinic visit. The participants are asked questions that measure eight health domains to assess physical and mental health. Physical health-related domains include: General health, Physical Functioning, Role Physical, and Body Pain. Mental health-related scales include Vitality, Social Functioning, Role Emotional, and Mental Health. A 3 and 5 point Likert scale is used in the survey. Two summary scores of the physical and mental health using weighted means of the eight domains. Descriptive statistics will be used to summarize pain relief and quality of life at each follow up visit, which will be the changes in scores from baseline to each assessment visit. Time to maximum pain relief will be the time from the day of thermal ablation until the lowest pain score for average pain after radiotherapy.
Measuring Quality of life (QOL) assessed by Brief Pain Inventory Survey (BPI)
We are measuring quality of life with the Brief Pain Inventory Survey that will be assessed during each follow up Clinic visit. The patient survey will be assessed to measure postoperative response to treatment. Participants are asked to assess the severity of pain and the impact of pain on daily functions. Severity of pain, including the pain location, worst pain in the last 24 hours, least pain in the last 24 hours, pain on average and pain right now. Range 0-10: a score of 0 would mean no pain and a score of 10 means the pain is as bad as you can imagine. Pain medications, amount of pain relief in the past 24 hours, and impact of pain on daily function, including general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life, and range 0-10.
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Henry Ford Health System
Lead sponsor
Medtronic
Collaborator
