D20054;LITT for Spine Tumors

Dartmouth Health

Status: Enrolling

Conditions: Spinal Metastases

Treatments: Device: ClearPoint Prism

Study type: Interventional

Funder types: Other

Identifiers

NCT06548061

STUDY02001761

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Spinal Laser Interstitial Thermal Therapy (sLITT)

Experimental group

Description:

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

Treatment:

Device: ClearPoint Prism