NCT06548061

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
37mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
May 2024Jun 2029

First Submitted

Initial submission to the registry

March 9, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 16, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

March 9, 2023

Last Update Submit

February 4, 2026

Conditions

Spinal Metastases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluate neurologic function before and after sLITT.

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

Study Arms (1)

Spinal Laser Interstitial Thermal Therapy (sLITT)

EXPERIMENTAL

Patients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device.

Device: ClearPoint Prism

Interventions

ClearPoint PrismDEVICE

Spine laser interstitial therapy used instead of open decompression followed by spine stereotactic radiosurgery (SSRS).

Spinal Laser Interstitial Thermal Therapy (sLITT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Health

Lebanon, New Hampshire, 03766, United States

RECRUITING

Central Study Contacts

Lauren Sinks, MPH

CONTACT

603-650-6380lauren.j.sinks@hitchcock.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuro-oncology, Principle Investigator, Assistant Professor

Study Record Dates

First Submitted

March 9, 2023

First Posted

August 12, 2024

Study Start

May 16, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(1)