Clinical trial NCT05023772: Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
Official title: A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasm Metastasis
Spinal Cord Diseases
Spinal Cord Compression
Spinal Cord Tumor
Spine Metastases
Keywords: Laser Ablation
Spinal Cord
Minimally Invasive Surgical Procedure
Stereotactic Radiosurgery
Pain Control
Metastasis
Epidural Tumor
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2021-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label one arm. Unblinded.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Exclusion Criteria:

* Requires open spinal procedure or a percutaneous procedure without the use of image guidance.
* Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases.
* Unable to tolerate general anesthesia and prone position.
* Unable to undergo MRI scan of the spine.
* Inability to lie flat on a treatment table for \>60 minutes.
* Pregnant. (Urine testing must be done no more than 10 days prior to surgery.)
* Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.
* Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength \<4/5 in extremity or extremities affected by the level of the spinal cord compression)

Primary outcomes:
measure: Local Tumor Control Rate
timeFrame: up to 24 months
Secondary outcomes:
measure: Local Tumor Control
timeFrame: 1, 3, 6, 9, 12, 18, and 24 months
measure: Postoperative response to treatment assessed by MRI
timeFrame: 1, 3, 6, 9, 12, 18, and 24 months
measure: Adverse Events
timeFrame: up to 24 months
measure: Overall Survival
timeFrame: 6, 12, 18, and 24 months
measure: Changes in symptoms assessed by physical examination
timeFrame: 1, 3, 6, 9, 12, 18, 24 months and annually thereafter
measure: Changes in symptoms assessed by neurological examination
timeFrame: 1, 3, 6, 9, 12, 18, and 24 months
Other outcomes:
measure: Measuring Quality of life (QOL) assessed by Spine Tumor Survey (MDASI-SP)
timeFrame: baseline and 1, 3, 6, 9, 12, 18, and 24 months
measure: Measuring Quality of life (QOL) assessed by Health Survey (SF-36)
timeFrame: baseline and 1, 3, 6, 9, 12, 18, and 24 months
measure: Measuring Quality of life (QOL) assessed by Brief Pain Inventory Survey (BPI)
timeFrame: baseline and 1, 3, 6, 9, 12, 18, and 24 months
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health Health System
name: Ian Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: