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

Trial Summary

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 data supports the effectiveness of the treatment Spinal Laser Interstitial Therapy for spinal metastases?

Research shows that Spinal Laser Interstitial Therapy, especially when combined with spinal stereotactic radiosurgery, can effectively control spinal metastases and relieve pain in patients who are not suitable for major surgery. This minimally invasive approach has been successfully used in over 100 cases, providing durable local control and symptom improvement. ^{1 2 3 4 5}

Is laser therapy for spinal metastases safe for humans?

Laser interstitial thermal therapy (LITT) for spinal metastases is considered minimally invasive and has been used safely in various cases, including for spinal tumors and brain tumors. Patients have undergone the procedure without complications, and it is often combined with other treatments like radiosurgery to improve outcomes. ^{2 3 4 6 7}

How is Spinal Laser Interstitial Therapy different from other treatments for spinal metastases?

Spinal Laser Interstitial Therapy is unique because it is a minimally invasive treatment that uses heat to destroy cancer cells in the spine, and it can be combined with spinal stereotactic radiosurgery to enhance effectiveness. This approach is particularly beneficial for patients who cannot undergo major surgery, and it allows for precise targeting of tumors with the help of MRI guidance. ^{1 2 3 4 8}

What is the purpose of this trial?

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. The investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States 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. [2022]

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

Percutaneous Hybrid Therapy for Spinal Metastatic Disease: Laser Interstitial Thermal Therapy and Spinal Stereotactic Radiosurgery. [2020]

3. 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]

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

Laser interstitial thermal therapy for palliative ablation of a chordoma metastasis to the spine: case report. [2017]

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

Association of spinal instability due to metastatic disease with increased mortality and a proposed clinical pathway for treatment. [2020]

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

Laser Interstitial Thermal Therapy for the Treatment of Primary and Metastatic Brain Tumors: A Systematic Review and Meta-Analysis. [2023]

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

Laser interstitial thermal therapy of the spine: technical aspects. [2019]

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

Emerging Percutaneous Ablative and Radiosurgical Techniques for Treatment of Spinal Metastases. [2020]