NCT05023772

Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases

A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm Metastasis
• Spinal Cord Diseases
• Spinal Cord Compression
• Spinal Cord Tumor
• Spine Metastases

Interventions

Type	Name	Description
PROCEDURE	Stereotactic Laser Ablation	MR Guided laser ablation therapy
RADIATION	Stereotactic Radiosurgery	Precise delivery of radiation to spinal tumor
DIAGNOSTIC_TEST	MRI guided laser ablation	Surgery will take place in intraoperative suite to include operating room and MRI scanner

Timeline

• Start date: 2021-09-02
• Primary completion: 2026-06-01
• Completion: 2026-12-20
• First posted: 2021-08-27
• Last updated: 2025-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study