D20054;LITT for Spine Tumors

August 4, 2026 updated by: Linton T. Evans, Dartmouth-Hitchcock Medical Center

Single Center Observational Study Using Spinal Laser Interstitial Thermal Therapy (sLITT) in the Treatment of Spine Metastases and 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. The investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histology confirmed spinal tumor involving the T2-T12 spine segments.
  2. Indication for spine stereotactic radiosurgery or palliative intervention.
  3. Normal neurologic exam at the time of presentation (Frankel grade E).

Exclusion Criteria:

  1. Contraindication to MRI
  2. ANY neurologic deficit
  3. Tumor spanning more than 3 consecutive vertebral segments
  4. Contraindication to general anesthesia
  5. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinal Laser Interstitial Thermal Therapy (sLITT)
Patients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device.
Device: ClearPoint Prism
Spine laser interstitial therapy used instead of open decompression followed by spine stereotactic radiosurgery (SSRS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tumor control
Time Frame: Local control rate at 12 months
Any increase in the epidural spinal cord compression score (ESCC grade 1 (no compression) to 3 (spinal cord compression) compared to the initial post-procedure MRI will be considered local radiographic failure or evidence of tumor recurrence.
Local control rate at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate neurologic function before and after sLITT.
Time Frame: 3, 6, 9, and 12 months post-operatively
Using Frankel score. Frankel scores (scale form A to E where A= complete loss of motor and sensory function, B= complete motor paralysis but some sensory function, C= some motor function but not usable, D= weakened but usable motor function, E= neurologically intact)
3, 6, 9, and 12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2028

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02001761

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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