Neoplasm Metastasis, Spinal Cord Compression, Spinal Cord Diseases, Spinal Cord Tumor, Spine Metastases
Conditions
Keywords
Laser Ablation, Spinal Cord, Minimally Invasive Surgical Procedure, Stereotactic Radiosurgery, Pain Control, Metastasis, Epidural Tumor
Brief 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.
Detailed 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 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.
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
Sponsors
Henry Ford Health System
Medtronic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label one arm. Unblinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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). * ECOG performance status \<2 or Karnofsky performance status (KPS) \>50 * Life expectancy \>3 months. * Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval. * Signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Control Rate | up to 24 months | Kaplan-Meier estimates will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Control | 1, 3, 6, 9, 12, 18, and 24 months | Time to local failure will be monitored continuously using Bayesian method. |
| Postoperative response to treatment assessed by MRI | 1, 3, 6, 9, 12, 18, and 24 months | 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 | up to 24 months | To describe adverse side effects after treatment and descriptively correlate those effects with radiographic findings, pain control, and quality of life. |
| Overall Survival | 6, 12, 18, and 24 months | Kaplan-Meier estimates will be used. |
| Changes in symptoms assessed by physical examination | 1, 3, 6, 9, 12, 18, 24 months and annually thereafter | 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. |
| Changes in symptoms assessed by neurological examination | 1, 3, 6, 9, 12, 18, and 24 months | 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. |
Countries
United States
Contacts
CONTACTRAMONA DAVIS
CONTACTREHNUMA NEWAZ
PRINCIPAL_INVESTIGATORIan Lee, MD
Henry Ford Health Health System
Outcome results
None listed