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

NCT05023772 | Recruiting DMC FDA Device

• 1 other identifier: 14622
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Local Tumor Control Rate

  Kaplan-Meier estimates will be used.

  up to 24 months

Secondary Outcomes (6)

• Local Tumor Control

  1, 3, 6, 9, 12, 18, and 24 months

• Postoperative response to treatment assessed by MRI

  1, 3, 6, 9, 12, 18, and 24 months

• Adverse Events

  up to 24 months

• Overall Survival

  6, 12, 18, and 24 months

• Changes in symptoms assessed by physical examination

  1, 3, 6, 9, 12, 18, 24 months and annually thereafter

Other Outcomes (3)

• Measuring Quality of life (QOL) assessed by Spine Tumor Survey (MDASI-SP)

  baseline and 1, 3, 6, 9, 12, 18, and 24 months

• Measuring Quality of life (QOL) assessed by Health Survey (SF-36)

  baseline and 1, 3, 6, 9, 12, 18, and 24 months

• Measuring Quality of life (QOL) assessed by Brief Pain Inventory Survey (BPI)

  baseline and 1, 3, 6, 9, 12, 18, and 24 months

Study Arms (1)

Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery

EXPERIMENTAL

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.

Procedure: Stereotactic Laser Ablation; Radiation: Stereotactic Radiosurgery; Diagnostic Test: MRI guided laser ablation

Interventions

Stereotactic Laser Ablation PROCEDURE

MR Guided laser ablation therapy

Also known as: Thermal laser ablation therapy, Visualase laser ablation therapy

Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery

Stereotactic Radiosurgery RADIATION

Precise delivery of radiation to spinal tumor

Also known as: CT guided stereotactic radiosurgery, Stereotactic external beam radiation therapy

Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery

MRI guided laser ablation DIAGNOSTIC_TEST

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

Also known as: Intraoperative MRI

Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead
• Medtronic: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Spinal Cord Diseases; Spinal Cord Compression; Spinal Cord Neoplasms; Agnosia; Epidural Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ian Lee, MD

  Henry Ford Health Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RAMONA DAVIS

CONTACT

3132821753; RDavis18@hfhs.org

REHNUMA NEWAZ

CONTACT

3139164123; RNewaz1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of the Hermelin Brain Tumor Center

Model Details: Open Label one arm. Unblinded.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: August 27, 2021
• Study Start: September 2, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)