NCT05023772 · Henry Ford Health System
Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
What this study 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.
View original scientific description
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.
Interventions
PROCEDURE
Stereotactic Laser Ablation
MR Guided laser ablation therapy
RADIATION
Stereotactic Radiosurgery
Precise delivery of radiation to spinal tumor
DIAGNOSTIC_TEST
MRI guided laser ablation
Surgery will take place in intraoperative suite to include operating room and MRI scanner
Primary outcome measures
Local Tumor Control Rate
Time frame: up to 24 months
Kaplan-Meier estimates will be used.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age \> 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
- Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see
Exclusion criteria
- ), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.
- 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. Exclusion Criteria:
- 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)
Where
- Detroit, Michigan
Collaborators
Medtronic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations