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

NCT ID: NCT05023772

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-02
• Study Completion Date: 2026-12-20

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery

Patients will undergo laser interstitial thermal ablation and CT guided stereotactic radiosurgery via intensity-modulated radiation therapy on different dates within a one to fourteen day window. The order of treatment is at the treating physicians discretion.

Group Type: EXPERIMENTAL

Stereotactic Laser Ablation

Intervention Type: PROCEDURE

MR Guided laser ablation therapy

Stereotactic Radiosurgery

Intervention Type: RADIATION

Precise delivery of radiation to spinal tumor

MRI guided laser ablation

Intervention Type: DIAGNOSTIC_TEST

Surgery will take place in intraoperative suite to include operating room and MRI scanner

Interventions

Stereotactic Laser Ablation

MR Guided laser ablation therapy

Intervention Type: PROCEDURE

Stereotactic Radiosurgery

Precise delivery of radiation to spinal tumor

Intervention Type: RADIATION

MRI guided laser ablation

Surgery will take place in intraoperative suite to include operating room and MRI scanner

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Thermal laser ablation therapy; Visualase laser ablation therapy; CT guided stereotactic radiosurgery; Stereotactic external beam radiation therapy; Intraoperative MRI

Eligibility Criteria

Inclusion Criteria

• Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.)

Exclusion Criteria

• 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.

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Ian Lee, MD

Co-Director of the Hermelin Brain Tumor Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health Health System

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

RAMONA DAVIS

Role: CONTACT

RDavis18@hfhs.org

3132821753

REHNUMA NEWAZ

Role: CONTACT

RNewaz1@hfhs.org

3139164123

Facility Contacts

RAMONA DAVIS

Role: primary

RDavis18@hfhs.org

313-282-1753

REHNUMA NEWAZ

Role: backup

RNewaz1@hfhs.org

3139164123

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

14622

Identifier Type: -

Identifier Source: org_study_id