Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05023772

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

Led by Henry Ford Health System · Updated on 2025-06-26

60

Participants Needed

1

Research Sites

276 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

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

Official 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 > 18 years old
  • Histologic diagnosis of solid malignant tumor (non-radiosensitive types) including non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, or unknown primary tumors
  • Epidural spinal cord compression graded 1C, 2, or 3 by MRI
  • Vertebral body site to be treated located from T2 to L1
  • No more than 3 vertebral levels involved with metastasis to be irradiated in one or three sessions
  • Motor strength 4 or higher out of 5 in affected limbs
  • ECOG performance status less than 2 or Karnofsky performance status greater than 50
  • Life expectancy greater than 3 months
  • Disease is inoperable due to refusal, neurosurgical evaluation, or other medical reasons
  • Agreement to use adequate contraception during study participation for women of child-bearing potential and men
  • Prior conventional radiation allowed if more than 3 months have passed since last treatment at the same site
  • Signed informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

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Research Team

R

RAMONA DAVIS

CONTACT

R

REHNUMA NEWAZ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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