NCT05023772 Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
| NCT ID | NCT05023772 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henry Ford Health System |
| Condition | Neoplasm Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-09-02 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-09-02 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Ian Lee, MD
PRINCIPAL INVESTIGATOR
Henry Ford Health Health System
Frequently Asked Questions
Who can join the NCT05023772 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasm Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05023772 currently recruiting?
Yes, NCT05023772 is actively recruiting participants. Contact the research team at RDavis18@hfhs.org for enrollment information.
Where is the NCT05023772 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT05023772 clinical trial?
NCT05023772 is sponsored by Henry Ford Health System. The principal investigator is Ian Lee, MD at Henry Ford Health Health System. The trial plans to enroll 60 participants.