D20054;LITT for Spine Tumors

Not Applicable

Recruiting

• Conditions: Spinal Metastases
• Interventions: Device: Visualase Thermal Therapy System

• Registration Number: NCT06548061
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-09
• Study Start: 2024-05-16
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2029-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Laser Interstitial Thermal Therapy (sLITT)	Visualase Thermal Therapy System	Patients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device.

Primary Outcome Measures

Name	Time	Method
Local tumor control	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate neurologic function before and after sLITT.	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)

Trial Locations

Locations (1)

Dartmouth Health; 🇺🇸 Lebanon, New Hampshire, United States