Menu
Not yet recruiting NCT06548061

D20054;LITT for Spine Tumors

No phase Interventional Spinal Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ClearPoint Prism.
Who it may be relevant to
Registry conditions: Spinal Metastases. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Single Center Observational Study Using Spinal Laser Interstitial Thermal Therapy (sLITT) in the Treatment of Spine Metastases and Tumors

Overview

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.

Interventions

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

Primary outcome measures

  • Local tumor control [Time frame: Local control rate at 12 months]
Secondary outcome measures (1)
  • Evaluate neurologic function before and after sLITT. [Time frame: 3, 6, 9, and 12 months post-operatively]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Dartmouth Health — Lebanon

Identifiers

NCT: NCT06548061 · STUDY02001761

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗