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NCT Number: NCT06548061

D20054;LITT for Spine Tumors

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.

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Key information

Conditions

Spinal Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Health

Lebanon, New Hampshire, 03766, United States

Location status: Recruiting

Location contact

Lauren Sinks, MPH

CONTACT

[email protected]

(603) 653-9021

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Contraindication to MRI
  • ANY neurologic deficit
  • Tumor spanning more than 3 consecutive vertebral segments
  • Contraindication to general anesthesia
  • Pregnancy

Treatment and study plan

ClearPoint Prism

Device

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

Primary outcomes

  1. Local tumor control

    Time frame: 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 outcomes

  1. Evaluate neurologic function before and after sLITT.

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Sinks, MPH

CONTACT

[email protected]

603-650-6380

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Aug 12, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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