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Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05023772

A Clinical Trial Evaluating Laser Interstitial Thermal Ablation Combined With Spine Stereotactic Radiosurgery for Patients With Spine Metastases

Led by Henry Ford Health System · Updated on 2026-06-03

60

Participants Needed

1

Research Sites

41 weeks

Total Duration

On this page

Sponsors

H

Henry Ford Health System

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a combination of spinal interstitial laser ablation and stereotactic spine radiosurgery SSRS to treat spinal tumors near the spinal cord, especially in patients with spinal metastasis that includes an epidural component. The study aims to improve tumor control, pain relief, preserve function, and enhance quality of life while documenting safety and accuracy of MRI-compatible hardware used for image guidance. This research measures how effective these combined treatments are compared to historical controls using SSRS alone. Participants will receive laser interstitial thermal ablation and CT-guided stereotactic radiosurgery, delivered via intensity-modulated radiation therapy, on separate days within a one to fourteen day window. The order of treatments is decided by the treating physician. Surgery occurs in an intraoperative suite equipped with an operating room and MRI scanner to guide the laser ablation precisely. During the study, participants will have regular assessments including MRI scans to monitor tumor control and epidural tumor regression at multiple time points up to 24 months. Researchers will also evaluate overall survival, muscle strength, pain levels, sensory and neurological function, ability to walk, and quality of life using validated tools. Adverse events will be tracked and correlated with imaging and symptom changes. The study involves ongoing follow-up visits for up to two years after treatment to measure outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years old
  • Histologic diagnosis of solid malignant tumor excluding radiosensitive subtypes
  • Degree of epidural spinal cord compression graded as 1C, 2, or 3 by MRI
  • Tumor located from vertebral level T2 to L1
  • No more than 3 vertebral levels involved with metastasis
  • Motor strength 4 or greater out of 5 in affected extremities
  • ECOG performance status less than 2 or Karnofsky performance status greater than 50
  • Life expectancy greater than 3 months
  • Disease is inoperable due to patient refusal, neurosurgical evaluation, or medical reasons
  • Agreement to use adequate contraception during study participation
  • Prior conventional radiation allowed if interval is greater than 3 months
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Requires open spinal procedure or percutaneous procedure without image guidance
  • Primary tumors of radiosensitive histology such as lymphoma, multiple myeloma, small cell carcinoma, or germ cell tumors
  • Unable to tolerate general anesthesia and prone position
  • Unable to undergo MRI scan of the spine
  • Unable to lie flat on treatment table for more than 60 minutes
  • Pregnant women
  • Prior conventional irradiation to spine site with interval less than 3 months
  • Frank cord compression from bone or acute neurological deficits with motor strength less than 4 out of 5

Research Team

R

RAMONA DAVIS

R

REHNUMA NEWAZ

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