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Trial Title:
D20054;LITT for Spine Tumors
NCT ID:
NCT06548061
Condition:
Spinal Metastases
Conditions: Official terms:
Neoplasm Metastasis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Visualase Thermal Therapy System
Description:
Spine laser interstitial therapy used instead of open decompression followed by SSRS.
Arm group label:
Spinal Laser Interstitial Thermal Therapy (sLITT)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
June 1, 2029
Lead sponsor:
Agency:
Dartmouth-Hitchcock Medical Center
Agency class:
Other
Source:
Dartmouth-Hitchcock Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06548061
