Spinal MetastasesNCT06548061
D20054;LITT for Spine Tumors
A study testing ClearPoint Prism in people with Spinal Metastases, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- ClearPoint Prism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2028to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Contraindication to MRI
- ANY neurologic deficit
- Tumor spanning more than 3 consecutive vertebral segments
- Contraindication to general anesthesia
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dartmouth Health
Lebanon, New Hampshire, 03766
Lauren Sinks, MPH, (603) 653-9021, lauren.j.sinks@hitchcock.org
About this study
Official title: Single Center Observational Study Using Spinal Laser Interstitial Thermal Therapy (sLITT) in the Treatment of Spine Metastases and 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.
- Conditions
- Spinal Metastases
- Being tested
- ClearPoint Prism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearPoint PrismDevice
Spine laser interstitial therapy used instead of open decompression followed by spine stereotactic radiosurgery (SSRS).
| Study group | Role | What they receive |
|---|---|---|
| Spinal Laser Interstitial Thermal Therapy (sLITT) | Experimental | Patients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device. Receives: Device: ClearPoint Prism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Local control rate at 12 months
Secondary outcomes (1)
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)
Measured: 3, 6, 9, and 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Jan 2028 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linton T. Evans, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548061
- Sponsor's protocol ID
- STUDY02001761
- Status last verified
- Feb 2026
- First submitted
- 9 Mar 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Observational Study Using Spinal Laser Interstitial Thermal Therapy (sLITT) in the Treatment of Spine Metastases and Tumors
- ClinicalTrials.gov ID
- NCT06548061
- Acronym / sponsor ID
- STUDY02001761
- Conditions
- Spinal Metastases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Laser Interstitial Thermal Therapy (sLITT) | Experimental | Device: ClearPoint PrismPatients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- Contraindication to MRI
- ANY neurologic deficit
- Tumor spanning more than 3 consecutive vertebral segments
- Contraindication to general anesthesia
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearPoint PrismSpine laser interstitial therapy used instead of open decompression followed by spine stereotactic radiosurgery (SSRS). | Device | Spinal Laser Interstitial Thermal Therapy (sLITT) |
Primary outcome
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.
1 secondary outcome
Evaluate neurologic function before and after sLITT.
Time frame: 3, 6, 9, and 12 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearPoint Prism in people with Spinal Metastases, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Sinks, MPH (603-650-6380, lauren.j.sinks@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor control (time frame: Local control rate at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.