Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06548061

Single Center Observational Study Using Spinal Laser Interstitial Thermal Therapy for Spine Metastases and Tumors

Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-02-06

25

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new treatment called spinal laser interstitial therapy for people with metastatic spinal tumors. This study aims to compare how well this laser therapy controls tumor growth locally with the results from traditional open surgery. The goal is to see if this less invasive laser treatment offers similar tumor control while monitoring safety. Participants will receive surgery using the Visualase Thermal Therapy System, a laser device designed to treat spinal tumors. This method is studied as an alternative to open decompression surgery, followed by spine stereotactic radiosurgery. The study focuses on tumors located in the T2-T12 segments of the spine. During the study, researchers will assess tumor control rates at 12 months after treatment. Neurologic function will also be evaluated before surgery and at 3, 6, 9, and 12 months post-operation. Participants will be closely monitored to track outcomes and safety throughout the follow-up period, which extends up to one year after treatment.

CONDITIONS

Brief Title

D20054;LITT for Spine Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histology confirmed spinal tumor involving the T2-T12 spine segments
  • Indication for spine stereotactic radiosurgery or palliative intervention
  • Normal neurologic exam at the time of presentation (Frankel grade E)
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Contraindication to MRI
  • Any neurologic deficit
  • Tumor spanning more than 3 consecutive vertebral segments
  • Contraindication to general anesthesia
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week

Participants undergo spine laser interstitial thermal therapy (sLITT) surgery using the Visualase Thermal Therapy System device followed by immediate post-operative care.

1 surgical visit and several immediate post-operative visits

Post-operative Follow-up

Duration - 12 months

Participants are followed to evaluate neurologic function and local tumor control after surgery.

Visits at 3, 6, 9, and 12 months post-operatively

Trial Site Locations

Total: 1 location

1

Dartmouth Health

Lebanon, New Hampshire, United States, 03766

Actively Recruiting

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Research Team

L

Lauren Sinks, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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