D20054;LITT for Spine Tumors

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: Recruiting
• Conditions: Spinal Metastases
• Intervention / Treatment: Device: ClearPoint Prism

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Sinks, MPH; Phone Number: 603-650-6380; Email: lauren.j.sinks@hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Recruiting
      • Dartmouth Health
      • Contact: Lauren Sinks, MPH; Phone Number: (603) 653-9021; Email: lauren.j.sinks@hitchcock.org

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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	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.	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

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

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): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• 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