Trial Summary
What is the purpose of this trial?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.
What safety data exists for laser ablation and radiosurgery for spinal cancer?The safety data for laser ablation and radiosurgery, particularly MRI-guided laser interstitial thermal therapy (LITT) and stereotactic body radiation therapy (SBRT), includes several findings. Complications in LITT are underreported, but a study using the Medtronic Visualase system found adverse events in 22.4% of procedures, including catheter malpositions, intracranial hemorrhages, and neurological deficits due to thermal injury. The use of frameless stereotaxy and multiple devices increased complication rates. For SBRT, precise image guidance is crucial to protect the spinal cord, the dose-limiting organ-at-risk. MRI guidance is preferred over conventional X-ray imaging for better visualization and safety. Overall, while these treatments show promise, careful technique and monitoring are essential to minimize risks.148914
Is the treatment 'MRI guided laser ablation, Stereotactic Laser Ablation, Stereotactic Radiosurgery' promising for spinal cancer?Yes, this treatment is promising for spinal cancer. It has been shown to effectively control pain and improve quality of life for patients with spinal metastases. It also offers a good balance between effectiveness and minimizing side effects, making it a valuable option for treating spinal cancer.35111213
What data supports the idea that Laser Ablation + Radiosurgery for Spinal Cancer is an effective treatment?The available research shows that Laser Ablation + Radiosurgery is a promising treatment for spinal cancer. One study highlights that this combination can help control the disease and reduce pain in patients who cannot undergo major surgery. Another study mentions that using MRI guidance during the treatment allows for precise targeting of the cancer, which can improve outcomes. Overall, these studies suggest that this treatment is effective, especially for patients with specific needs or conditions.2671012
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.
Eligibility Criteria
This trial is for adults over 18 with inoperable spinal tumors from T2 to L1, not due to highly radiosensitive cancers like lymphoma. They must have a life expectancy over 3 months, agree to contraception if applicable, and be able to tolerate anesthesia and MRI scans. Participants should not be pregnant or have had recent radiation therapy on the same spine area.Inclusion Criteria
I can carry out all self-care but may not be able to do heavy physical work.
I can move my arms or legs where my spine is compressed fairly well.
The part of my spine needing treatment is between my upper back and mid-back.
I am older than 18 years.
My MRI shows I have a significant spinal cord compression.
My spine cancer affects no more than 3 separate or connected areas.
My cancer is a solid tumor and not highly sensitive to radiation.
Exclusion Criteria
I cannot undergo surgery with general anesthesia or lie face down.
I have spinal cord compression causing sudden nerve problems.
I cannot lie flat for more than an hour.
My cancer type is known to respond well to radiation therapy.
I need a surgery on my spine without using cameras or screens for guidance.
Treatment Details
The study tests combining laser interstitial thermal ablation (LITA) with stereotactic spine radiosurgery (SSRS) for treating spinal metastases near the cord. It aims to see if this combo improves tumor control, pain relief, function preservation, and overall quality of life.
1Treatment groups
Experimental Treatment
Group I: Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic RadiosurgeryExperimental Treatment3 Interventions
Patients will undergo laser interstitial thermal ablation and CT guided stereotactic radiosurgery via intensity-modulated radiation therapy on different dates within a one to fourteen day window. The order of treatment is at the treating physicians discretion.
MRI guided laser ablation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as MRI-guided LITT for:
- Spinal metastases
- Epidural spinal cord compression
🇪🇺 Approved in European Union as sLITT for:
- Spinal metastases
- Epidural spinal cord compression
Find a clinic near you
Research locations nearbySelect from list below to view details:
Henry Ford HospitalDetroit, MI
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Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
MedtronicIndustry Sponsor
References
Volumetric trends associated with MRI-guided laser-induced thermal therapy (LITT) for intracranial tumors. [2022]MR-guided Laser Induced Thermal Therapy (LITT) is a procedure for intracranial tumors. Minimal data exists regarding post-procedure lesion volume changes.
Magnetic resonance-guided laser ablation improves local control for postradiosurgery recurrence and/or radiation necrosis. [2022]Enhancing lesions that progress after stereotactic radiosurgery are often tumor recurrence or radiation necrosis. Magnetic resonance-guided laser-induced thermal therapy (LITT) is currently being explored for minimally invasive treatment of intracranial neoplasms.
Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. [2019]Stereotactic body radiation therapy (SBRT) appears an effective and safe treatment modality for spinal bone metastasis, which can enhance local control and improve quality of life. Life expectation, predicted fracture risk, localization, quality, size and number of metastasis and presence or absence of nerve compression seem to be important factors in decision-making for treatment. Further studies are needed to identify subsets of patient which will most benefit from treatment.
Complication avoidance in laser interstitial thermal therapy: lessons learned. [2019]OBJECTIVE Complications of laser interstitial thermal therapy (LITT) are underreported. The authors discuss how they have modified their technique in the context of technical and treatment-related adverse events. METHODS The Medtronic Visualase system was used in 49 procedures in 46 patients. Between 1 and 3 cooling catheters/laser fiber assemblies were placed, for a total of 62 implanted devices. Devices were placed using frameless stereotaxy (n = 3), frameless stereotaxy with intraoperative MRI (iMRI) (n = 9), iMRI under direct vision (n = 2), MRI alone (n = 1), or frame-based (n = 47) techniques. LITT was performed while monitoring MRI thermometry. Indications included brain tumors (n = 12), radiation necrosis (n = 2), filum terminale ependymoma (n = 1), mesial temporal lobe epilepsy (n = 21), corpus callosotomy for bifrontal epilepsy (n = 3), cavernoma (n = 1), and hypothalamic hamartomas (n = 6). RESULTS Some form of adverse event occurred in 11 (22.4%) of 49 procedures. These included 4 catheter malpositions, 3 intracranial hemorrhages, 3 cases of neurological deficit related to thermal injury, and 1 technical malfunction resulting in an aborted procedure. Of these, direct thermal injury was the only cause of prolonged neurological morbidity and occurred in 3 of 49 procedures. Use of frameless stereotaxy and increased numbers of devices were associated with significantly increased complication rates (p
Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation. [2022]Stereotactic body radiotherapy (SBRT) is an emerging treatment option for spinal metastases with demonstrated efficacy in the upfront, postoperative, and re-treatment settings, as well as for tumor histologies considered radioresistant. Uncertainty exists regarding the optimal dose and fractionation schedule, with single and multifraction regimens commonly utilized.
A Novel Use of the Intraoperative MRI for Metastatic Spine Tumors: Laser Interstitial Thermal Therapy for Percutaneous Treatment of Epidural Metastatic Spine Disease. [2018]Spinal laser interstitial thermal therapy (LITT) appears to be a promising novel modality for treatment of epidural metastatic spine disease in patients who are poor candidates for larger-scale oncologic spinal surgery and can act synergetically with spinal stereotactic radiosurgery to maximize local control and palliate pain. This technique is ideally suited for the intraoperative MRI suite to monitor the extent of the ablation in the epidural space. As percutaneous navigation, imaging, and LITT technology improve, broader applicability of this minimally invasive technique in spinal oncology is foreseen.
MRI-guided stereotactic ablative radiation therapy of spinal bone metastases: a preliminary experience. [2022]MRI provides clear visualization of spinal cord, tumor, and bone for patient positioning and verification during MRI-guided radiotherapy (MRI-RT). Therefore, we wished to evaluate spine stereotactic ablative radiotherapy (SABR) feasibility with MRI-RT. Given dosimetric limitations of first generation Co-60 MRI-RT, we then evaluated improvements by newer linear accelerator (linac) MRI-RT.
Dosimetric Feasibility of Utilizing the ViewRay Magnetic Resonance Guided Linac System for Image-guided Spine Stereotactic Body Radiation Therapy. [2020]Spine stereotactic body radiation therapy (SBRT) achieves favorable outcomes compared to conventional radiotherapy doses/fractionation. The spinal cord is the principal dose-limiting organ-at-risk (OAR), and safe treatment requires precise immobilization/localization. Therefore, image guidance is paramount to successful spine SBRT. Conventional X-ray imaging and alignment to surrogate bony anatomy may be inadequate, whereas magnetic resonance imaging (MRI) directly visualizes the dose-limiting cord. This work assessed the dosimetric capability of the ViewRay (ViewRay Inc. Oakwood Village, OH) magnetic resonance (MR) guided linac (MR-Linac) for spine SBRT.
Highly realistic simulation for robot-assisted hypothalamic hamartoma real-time MRI-guided laser interstitial thermal therapy (LITT). [2021]Real-time MRI-guided laser interstitial thermal therapy (LITT) is a challenging procedure due to its technical complexity, as well as the need for efficient multidisciplinary teamwork and transfer of an anesthetized patient between operating room (OR) and magnetic resonance (MR). A highly realistic simulation was developed to design the safest process before being applied to real patients. In this report, authors address the description of the methodology used for this simulation and its purposefulness.
Laser interstitial thermotherapy (LITT) for the treatment of tumors of the brain and spine: a brief review. [2021]Laser Interstitial Thermotherapy (LITT; also known as Stereotactic Laser Ablation or SLA), is a minimally invasive treatment modality that has recently gained prominence in the treatment of malignant primary and metastatic brain tumors and radiation necrosis and studies for treatment of spinal metastasis has recently been reported.
Phase 2 Clinical Trial of Separation Surgery Followed by Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression. [2022]Stereotactic body radiation therapy (SBRT) is a postoperative treatment option for spinal metastases. Because data on surgery with SBRT are limited to retrospective studies, this single-center, single-arm, phase 2 study aimed to prospectively evaluate the outcomes of separation surgery and SBRT for metastatic epidural spinal cord compression (MESCC).
Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. [2022]Stereotactic body radiotherapy (SBRT) is used to deliver ablative dose of radiation to spinal metastases.
Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023]Stereotactic body radiotherapy (SBRT) has proven to be a highly effective treatment for selected patients with spinal metastases. Randomized evidence shows improvements in complete pain response rates and local control with lower retreatment rates favoring SBRT, compared to conventional external beam radiotherapy (cEBRT). While there are several reported dose-fractionation schemes for spine SBRT, 24 Gy in 2 fractions has emerged with Level 1 evidence providing an excellent balance between minimizing treatment toxicity while respecting patient convenience and financial strain.
A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. [2023]Stereotactic body radiation therapy (SBRT) has demonstrated safe and effective results for primary liver tumors. Magnetic Resonance guided Radiotherapy (MRgRT) is an innovative radiotherapy modality for abdominal tumors. The aim of this study is to report on acute and late toxicities and initial oncological results for primary liver tumors treated with MRgRT.