D20054;LITT for Spine Tumors

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06548061

Enrollment

Registered

2024-08-12

Start date

2028-01-01

Completion date

2031-06-30

Last updated

2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Metastases

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.

Interventions

DEVICEClearPoint Prism

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

United States

Contacts

CONTACTLauren Sinks, MPH

lauren.j.sinks@hitchcock.org603-650-6380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026