D20054;LITT for Spine Tumors

NCT ID: NCT06548061

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-16

Study Completion Date

2029-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spinal Laser Interstitial Thermal Therapy (sLITT)

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

Group Type EXPERIMENTAL

Visualase Thermal Therapy System

Intervention Type DEVICE

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

Interventions

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Visualase Thermal Therapy System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Linton T. Evans

Director, Neuro-oncology, Principle Investigator, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dartmouth Health

Lebanon, New Hampshire, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren Sinks, MPH

Role: CONTACT

603-650-6380

Facility Contacts

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Lauren Sinks, MPH

Role: primary

603-650-6380

Other Identifiers

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STUDY02001761

Identifier Type: -

Identifier Source: org_study_id

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