60 Participants Needed

Laser Ablation + Radiosurgery for Spinal Cancer

RD
RN
Overseen ByREHNUMA NEWAZ
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Henry Ford Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.111121314

Research Team

IL

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.
See 9 more

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
See 5 more

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
  • Stereotactic Laser Ablation
  • Stereotactic Radiosurgery
Trial OverviewThe 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
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:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as MRI-guided LITT for:
  • Spinal metastases
  • Epidural spinal cord compression
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as sLITT for:
  • Spinal metastases
  • Epidural spinal cord compression

Find a Clinic Near You

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 profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

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

References

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. [2022]
Laser interstitial thermotherapy (LITT) for the treatment of tumors of the brain and spine: a brief review. [2021]
Magnetic resonance-guided laser ablation improves local control for postradiosurgery recurrence and/or radiation necrosis. [2022]
A Novel Use of the Intraoperative MRI for Metastatic Spine Tumors: Laser Interstitial Thermal Therapy for Percutaneous Treatment of Epidural Metastatic Spine Disease. [2018]
MRI-guided stereotactic ablative radiation therapy of spinal bone metastases: a preliminary experience. [2022]
Volumetric trends associated with MRI-guided laser-induced thermal therapy (LITT) for intracranial tumors. [2022]
Complication avoidance in laser interstitial thermal therapy: lessons learned. [2019]
Dosimetric Feasibility of Utilizing the ViewRay Magnetic Resonance Guided Linac System for Image-guided Spine Stereotactic Body Radiation Therapy. [2020]
Highly realistic simulation for robot-assisted hypothalamic hamartoma real-time MRI-guided laser interstitial thermal therapy (LITT). [2021]
A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Phase 2 Clinical Trial of Separation Surgery Followed by Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023]
Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. [2019]