Actively Recruiting
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
Eligibility Criteria
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants undergo laser interstitial thermal ablation and stereotactic radiosurgery to treat spine metastases. Treatments occur on different dates within a one to fourteen day window.
2 visits (in-person) for laser ablation and radiosurgery
Duration - Up to 24 months
Participants are monitored for tumor control, tumor regression, symptom changes, adverse events, and overall survival after treatment.
Visits at 1, 3, 6, 9, 12, 18, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
R
RAMONA DAVIS
R
REHNUMA NEWAZ
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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