Laser Ablation + Radiosurgery for Spinal Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Ian Lee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Henry Ford Health System

Disqualifiers: Radiosensitive tumors, Pregnancy, MRI intolerance, others

No Placebo Group

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.

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{4 11 12 13 14}

Research Team

Ian Lee, MD

Principal Investigator

Henry Ford Health Health System

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.

I agree to use effective birth control during the study.

Exclusion Criteria

I cannot undergo surgery with general anesthesia or lie face down.

I have spinal cord compression causing sudden nerve problems.

Unable to undergo MRI scan of the spine

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laser interstitial thermal ablation and stereotactic radiosurgery for spinal tumors

1-2 weeks

Multiple visits for laser ablation and radiosurgery

Follow-up

Participants are monitored for safety, tumor control, and quality of life at regular intervals

24 months

Follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months

Long-term follow-up

Participants continue to be monitored for overall survival and quality of life

Annually after 24 months

Treatment Details

Interventions

• MRI guided laser ablation (Virus Therapy)
• Stereotactic Laser Ablation (Procedure)
• Stereotactic Radiosurgery (Radiation Therapy)

Trial Overview 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.

Participant Groups

Group I: Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

In a study involving 16 patients with recurrent brain lesions after radiosurgery, magnetic resonance-guided laser-induced thermal therapy (LITT) achieved a local control rate of 75.8% at a median follow-up of 24 weeks, indicating its efficacy in managing these challenging cases.

LITT was found to be a well-tolerated procedure, with a median progression-free survival of 37 weeks and an overall survival rate of 57%, suggesting it is a promising minimally invasive treatment option for patients with recurrent brain metastases or radiation necrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided laser ablation improves local control for postradiosurgery recurrence and/or radiation necrosis. Rao, MS., Hargreaves, EL., Khan, AJ., et al.[2022]

Spinal laser interstitial thermal therapy (LITT) is a promising treatment for patients with epidural metastatic spine disease who cannot undergo larger surgeries, offering a minimally invasive option.

LITT can work effectively alongside spinal stereotactic radiosurgery to enhance local control of the disease and help relieve pain, with the potential for broader use as imaging and navigation technologies improve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Use of the Intraoperative MRI for Metastatic Spine Tumors: Laser Interstitial Thermal Therapy for Percutaneous Treatment of Epidural Metastatic Spine Disease. Thomas, JG., Al-Holou, WN., de Almeida Bastos, DC., et al.[2018]

MRI-guided radiotherapy (MRI-RT) for spinal metastases is feasible using Co-60 technology, with successful treatment delivery and no observed toxicities in nine cases.

Switching to newer linear accelerator (linac) MRI-RT improves dose delivery and reduces dose spillage into surrounding tissues, enhancing the safety and efficacy of spinal stereotactic ablative radiotherapy (SABR).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided stereotactic ablative radiation therapy of spinal bone metastases: a preliminary experience. Llorente, R., Spieler, BO., Victoria, J., et al.[2022]

In a study of 93 patients with prostate cancer receiving stereotactic body radiotherapy (SBRT) for spinal metastases, local control rates were very high, with 99% at 1 year and 95% at 2 years for hormone-sensitive prostate cancer (HSPC), but lower for castrate-resistant prostate cancer (CRPC) at 94% and 78%, respectively.

The overall survival rates were significantly better for patients with HSPC, at 98% and 95% at 1 and 2 years, compared to 79% and 65% for those with CRPC, indicating that hormone sensitivity impacts both local control and survival outcomes after SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. Abugharib, A., Zeng, KL., Tseng, CL., et al.[2022]

Laser Interstitial Thermotherapy (LITT) is a minimally invasive treatment that has shown promise for various brain tumors, including recurrent glioblastoma, brain metastasis, and radiation necrosis, making it a safe and reliable option for deep-seated tumors.

Despite its growing use, there is a need for more well-designed prospective clinical trials to better define the effectiveness and role of LITT in treating brain and spine lesions, as most current studies lack rigorous design and often combine different types of tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser interstitial thermotherapy (LITT) for the treatment of tumors of the brain and spine: a brief review. Chen, C., Lee, I., Tatsui, C., et al.[2021]

In a study involving 49 procedures on 46 patients using laser interstitial thermal therapy (LITT), complications occurred in 22.4% of cases, including catheter malpositions and thermal injuries, but permanent neurological morbidity was rare.

The authors implemented several procedural modifications, such as using frame-based catheter placement and minimizing the number of probes, which significantly improved safety and reduced complication rates during LITT procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complication avoidance in laser interstitial thermal therapy: lessons learned. Pruitt, R., Gamble, A., Black, K., et al.[2019]

The study demonstrated that using the MR-Linac for spine stereotactic body radiation therapy (SBRT) is feasible and can improve cord sparing compared to traditional VMAT techniques, with a maximum dose to the spinal cord showing a trend towards reduction.

Real-time MRI visualization of the spinal cord during treatment may allow for more precise targeting and potentially safer treatment options, enabling adaptive therapy and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric Feasibility of Utilizing the ViewRay Magnetic Resonance Guided Linac System for Image-guided Spine Stereotactic Body Radiation Therapy. Redler, G., Stevens, T., Cammin, J., et al.[2020]

In a study of 16 patients undergoing MR-guided Laser Induced Thermal Therapy (LITT) for intracranial tumors, lesion volume peaked immediately after the procedure and then decreased significantly by 24 hours post-ablation, indicating a dynamic response to the treatment.

The study suggests that assessments of lesion size should be made at least 24 hours after LITT, as immediate post-ablation measurements showed lower reliability among raters, which could lead to misleading conclusions about treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumetric trends associated with MRI-guided laser-induced thermal therapy (LITT) for intracranial tumors. Patel, NV., Jethwa, PR., Barrese, JC., et al.[2022]

A highly realistic simulation for real-time MRI-guided laser interstitial thermal therapy (LITT) was developed using a modified mannequin, allowing the surgical team to practice the entire procedure safely before performing it on actual patients.

The simulation identified no critical errors in the process design and helped improve team coordination and safety during patient transfers, ultimately enhancing the efficiency of the surgical workflow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Highly realistic simulation for robot-assisted hypothalamic hamartoma real-time MRI-guided laser interstitial thermal therapy (LITT). Candela-Cantó, S., Alamar, M., Aláez, C., et al.[2021]

In a study involving 56 patients treated with Magnetic Resonance guided Radiotherapy (MRgRT) for primary liver tumors, no severe toxicities (greater than CTCAE grade 2) were observed, indicating a high safety profile for this treatment.

MRgRT achieved excellent local control rates of 98.1% at 12 months and 94.7% at 18 months, with an overall survival rate of 85.1% at 1 year, demonstrating its efficacy in managing primary liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. Bordeau, K., Michalet, M., Dorion, V., et al.[2023]

Stereotactic body radiation therapy (SBRT) is an effective and safe treatment for spinal bone metastasis, enhancing local control and improving patients' quality of life.

Key factors influencing treatment decisions include life expectancy, fracture risk, localization and size of metastases, and nerve compression, highlighting the need for further studies to identify which patients will benefit most from SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. Cihan, YB.[2019]

Stereotactic body radiotherapy (SBRT) for spinal metastases shows high local control rates exceeding 80% at one year, with effective pain management and low toxicity when strict dose constraints are followed.

There is no clear superiority between single and multifraction regimens in terms of local control and pain relief, but hypofractionated treatments may offer advantages in reducing toxicity compared to single-fraction regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation. Huo, M., Sahgal, A., Pryor, D., et al.[2022]

Stereotactic body radiotherapy (SBRT) using a regimen of 24 Gy in 2 fractions has shown high efficacy for treating spinal metastases, with 1-year local control rates between 83-93.9% and low rates of treatment-related complications, such as plexopathy and radiculopathy under 5%.

This SBRT regimen is not only effective for initial treatment but also feasible for reirradiation of previously treated spine metastases, maintaining local control rates of 72-86%, making it a strong option for patients with challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. Nguyen, EK., Ruschin, M., Zhang, B., et al.[2023]

In a phase 2 study involving 33 patients with metastatic epidural spinal cord compression (MESCC), separation surgery followed by stereotactic body radiation therapy (SBRT) resulted in a low 12-month local failure rate of 13%, indicating effective long-term local control of the disease.

After 12 months, 90% of patients showed improvement in their disease status, and 20 patients were able to walk normally or with assistance, demonstrating the treatment's efficacy in preserving ambulatory function with minimal severe adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 Clinical Trial of Separation Surgery Followed by Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression. Ito, K., Sugita, S., Nakajima, Y., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided laser ablation improves local control for postradiosurgery recurrence and/or radiation necrosis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Novel Use of the Intraoperative MRI for Metastatic Spine Tumors: Laser Interstitial Thermal Therapy for Percutaneous Treatment of Epidural Metastatic Spine Disease. [2018]

3. England pubmed.ncbi.nlm.nih.gov

MRI-guided stereotactic ablative radiation therapy of spinal bone metastases: a preliminary experience. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Laser interstitial thermotherapy (LITT) for the treatment of tumors of the brain and spine: a brief review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Complication avoidance in laser interstitial thermal therapy: lessons learned. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Dosimetric Feasibility of Utilizing the ViewRay Magnetic Resonance Guided Linac System for Image-guided Spine Stereotactic Body Radiation Therapy. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Volumetric trends associated with MRI-guided laser-induced thermal therapy (LITT) for intracranial tumors. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Highly realistic simulation for robot-assisted hypothalamic hamartoma real-time MRI-guided laser interstitial thermal therapy (LITT). [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. [2023]

11. Thailand pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Phase 2 Clinical Trial of Separation Surgery Followed by Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression. [2022]