Laser Ablation + Radiosurgery for Spinal Cancer

Overseen By REHNUMA NEWAZ

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Radiosensitive tumors, Pregnancy, MRI intolerance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for spinal tumors using a combination of laser ablation (MRI-guided laser interstitial thermal therapy) and stereotactic radiosurgery. The goal is to improve tumor control, reduce pain, and help maintain mobility and quality of life. The trial examines the effectiveness of this method for individuals with cancer that has spread to the spine, particularly near the spinal cord. Suitable candidates have a solid tumor diagnosis, tumors near the spinal cord, and retain fairly good mobility in their arms and legs. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MRI-guided laser ablation is generally safe. In one study of 120 cases, it proved effective and well-tolerated for treating spine problems. Another study found this method minimally invasive and reliable for treating brain and spine tumors, with few serious side effects.

For stereotactic radiosurgery, studies indicate a good safety record. It effectively controls pain and manages spinal tumors. One study noted that even after five years, many patients continued to benefit from this treatment with few major side effects.

Overall, both MRI-guided laser ablation and stereotactic radiosurgery appear well-tolerated, with research supporting their safety in treating spinal conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of laser ablation and radiosurgery for spinal cancer because it offers a precise and minimally invasive approach to targeting tumors. Unlike traditional methods that might involve open surgery or broad radiation treatment, this technique uses MRI-guided laser ablation to directly heat and destroy cancer cells while sparing surrounding healthy tissue. Moreover, the addition of stereotactic radiosurgery allows for a highly focused delivery of radiation, which can enhance the treatment's effectiveness within a shorter time frame. This dual approach has the potential to reduce recovery times and improve outcomes, making it a promising advancement in the management of spinal cancer.

What evidence suggests that this trial's treatments could be effective for spinal cancer?

Research has shown that MRI-guided laser ablation effectively treats spinal tumors. In a study with 120 cases, this method significantly reduced tumor size. It is considered safe and involves only a small procedure, making it a promising option for tumors located deep in the body.

Stereotactic radiosurgery, a precise type of radiation therapy, also yields strong results. Studies have found it provides excellent pain relief and good control over tumor growth. Specifically, one study reported that more than 45% of patients experienced complete pain relief within three months. In this trial, participants will receive both MRI-guided laser ablation and stereotactic radiosurgery, offering a powerful way to manage spinal cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Ian Lee, MD

Principal Investigator

Henry Ford Health Health System

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MRI guided laser ablation
• Stereotactic Laser Ablation
• Stereotactic Radiosurgery

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.

How Is the Trial Designed?

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.

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

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

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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 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]

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 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]

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]

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]

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]

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]

Citations

1. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/34/3/article-p354.xml

Spinal laser interstitial thermal therapy: single-center ... The objective of this study was to present the results of a consecutive series of 120 cases treated with spinal laser interstitial thermal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7897607/

Laser interstitial thermotherapy (LITT) for the treatment of ... LITT is emerging as a safe, reliable, minimally invasive clinical approach, particularly for deep seated, focal malignant brain tumors and radiation necrosis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11640510/

Evaluating the Accuracy and Efficiency of Imaging Modalities ... This research may help doctors choose the best imaging tools for treating spinal metastases, improving patient outcomes, and reducing risks.

4. aans.org aans.org/wp-content/uploads/aans_files/AANS/Advocacy/PDFS/AANS-CNS_Position_Statement_Paper_LITT_Tumor-Oncology_090721.pdf

Position Statement on MR-guided Laser Interstitial Thermal ... ... LITT has been shown to be an effective treatment option in order to achieve maximal cytoreduction of the tumor prior to the administration ...

5. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/23/4/article-p400.xml

Utilization of laser interstitial thermotherapy guided by real ... Real-time thermal MRI was used to monitor tissue damage in the region of interest. All patients received postoperative SSRS. The maximum ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33307530/

Spinal laser interstitial thermal therapy: single-center ... sLITT is safe and provides effective local control for high-grade ESCC from vertebral metastases in the thoracic spine, particularly when combined with ...

7. withpower.com withpower.com/trial/phase-spinal-cord-compression-8-2021-3a677

Laser Ablation + Radiosurgery for Spinal Cancer The safety data for laser ablation and radiosurgery, particularly MRI-guided laser interstitial thermal therapy (LITT) and stereotactic body radiation ...