Clinical trial · Interventional
D20054;LITT for Spine Tumors
Single Center Observational Study Using Spinal Laser Interstitial Thermal Therapy (sLITT) in the Treatment of Spine Metastases and Tumors
NCT06548061CI-TRIAL-00120919not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ClearPoint Prism | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Spinal Laser Interstitial Thermal Therapy (sLITT)
- description
- Patients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device.
- interventionNames
- Device: ClearPoint Prism
Primary outcomes (1)
- measure
- Local tumor control
- timeFrame
- Local control rate at 12 months
- description
- 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 outcomes (1)
- measure
- Evaluate neurologic function before and after sLITT.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.