Laser Therapy for Spinal Metastases

Overseen By Lauren Sinks, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Neurologic deficit, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 week

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser therapy, Spinal Laser Interstitial Therapy, for tumors that have spread to the spine. Researchers aim to determine if this laser treatment can control tumors as effectively as traditional surgery. Individuals with confirmed spinal tumors between the T2 and T12 spine areas, who require spinal radiation or a relief procedure and have a normal neurologic exam, might be suitable candidates. The goal is to identify a treatment option that is both effective and safe for those with these specific spinal tumors. As an unphased trial, this study provides patients the chance to explore innovative treatments that could enhance their quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that spinal laser interstitial therapy is safe for treating metastatic spinal tumors?

Research has shown that spinal laser interstitial therapy (sLITT) safely treats spinal tumors. Studies have found that sLITT eases pressure on the spinal cord with few side effects. One study demonstrated its effectiveness in controlling tumor growth, particularly in the upper and middle back. This treatment is minimally invasive, involving less cutting and generally being easier on the body. Previous reports confirm that patients tolerate sLITT well, making it a promising option for those with spinal metastases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Spinal Laser Interstitial Thermal Therapy (sLITT) is unique because it uses laser technology to precisely target and treat spinal metastases. Unlike traditional treatments like surgery or radiation, which can affect large areas and have longer recovery times, sLITT aims to minimize damage to surrounding healthy tissues and potentially shorten recovery periods. Researchers are excited about this treatment due to its minimally invasive nature and its potential to provide more effective pain relief and better quality of life for patients dealing with spinal metastases.

What evidence suggests that spinal laser interstitial therapy is effective for metastatic spinal tumors?

Research has shown that spinal laser interstitial thermal therapy (sLITT), which participants in this trial will receive, effectively controls tumors in the spine. Studies have demonstrated that sLITT helps manage epidural spinal cord compression, a condition that occurs when cancer spreads to the spine. In a study of 120 cases, sLITT provided good tumor control while remaining safe. A review of multiple studies found that sLITT effectively relieves pressure on the spinal cord with few complications. These findings suggest that sLITT can be a safe and effective option for treating cancer that has spread to the spine. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with confirmed spinal tumors in the T2-T12 spine segments who need radiosurgery or palliative care. They must have normal neurological function (Frankel grade E) at the start. Specific details on who cannot join are not provided.

Inclusion Criteria

My spinal tumor is located between the T2 and T12 vertebrae.

I need targeted radiation or palliative care for my spine.

My neurological exam shows normal function.

Exclusion Criteria

Contraindication to MRI

Pregnancy

I cannot have general anesthesia due to health risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo spinal laser interstitial thermal therapy using the Visualase Thermal Therapy System

1 week

1 visit (in-person)

Follow-up

Participants are monitored for local tumor control and neurologic function post-operatively

12 months

4 visits (in-person) at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Laser Interstitial Therapy

Trial Overview

The study is testing the Visualase Thermal Therapy System's effectiveness and safety in treating metastatic spinal tumors, comparing it to conventional open surgical techniques for local tumor control.

How Is the Trial Designed?

Group I: Spinal Laser Interstitial Thermal Therapy (sLITT) Experimental Treatment 1 Intervention

Patients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

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]

Laser interstitial thermal therapy (LITT) is a minimally invasive treatment for brain tumors, showing a pooled incidence of procedure-related adverse events at 30%, with new neurologic deficits and postprocedural edema being the most common, though mostly transient.

The one-year overall survival rates were 43% for high-grade gliomas and 93% for low-grade gliomas, indicating that LITT can be a safe and effective option for certain patients, particularly those with low-grade tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser Interstitial Thermal Therapy for the Treatment of Primary and Metastatic Brain Tumors: A Systematic Review and Meta-Analysis. Alkazemi, M., Lo, YT., Hussein, H., et al.[2023]

Laser interstitial thermal therapy (LITT) demonstrated effective local control in 81.8% of patients with metastatic brain tumors or radiation necrosis, based on a study of 23 patients with at least 6 months of follow-up.

The median survival for patients after LITT treatment was 16 months, indicating a promising outcome for those with previously treated metastatic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Principles of Patient Selection for Laser Interstitial Thermal Therapy for Metastatic Brain Tumor Management: A Multisite Institutional Case Series. Riviere-Cazaux, C., Bhandarkar, AR., Rahman, M., et al.[2022]

Citations

1.

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 ...

2.

thejns.org

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

Spinal laser interstitial thermal therapy - Journal of Neurosurgery

The objective of this study was to present the results of a consecutive series of 120 cases treated with spinal laser interstitial thermal ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e14657

Efficacy and safety profile of spinal laser interstitial thermal ...

This meta-analysis evaluates the efficacy and safety of sLITT, a laser-based treatment that effectively relieves spinal cord pressure with low complication ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06548061

NCT06548061 | D20054;LITT for Spine Tumors

The objective of this clinical study is to evaluate the efficacy and safety of spinal laser interstitial therapy in the treatment of metastatic spinal tumors.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36181543/

The efficacy of laser interstitial thermal therapy in ...

sLITT is safe and provides effective local control for epidural compression from metastases, particularly in the thoracic spine.

6.

withpower.com

withpower.com/trial/phase-metastases-to-spine-9-2024-3f167

Laser Therapy for Spinal Metastases

Laser interstitial thermal therapy (LITT) for spinal metastases is considered minimally invasive and has been used safely in various cases, including for spinal ...