D20054;LITT for Spine Tumors

ConditionSpinal Metastases

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorDartmouth-Hitchcock Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Contraindication to MRI

ANY neurologic deficit

Tumor spanning more than 3 consecutive vertebral segments

Contraindication to general anesthesia

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: Spinal Laser Interstitial Thermal Therapy (sLITT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Local tumor control

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.

Time frame

Local control rate at 12 months

Secondary outcomes

Evaluate neurologic function before and after sLITT.

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)

Time frame

3, 6, 9, and 12 months post-operatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: