Neoplasm MetastasisNCT05023772
Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
A study testing Stereotactic Laser Ablation, Stereotactic Radiosurgery and MRI guided laser ablation in people with Neoplasm Metastasis and Spinal Cord Diseases, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis, Spinal Cord Diseases, Spinal Cord Compression
- What is being tested?
- Stereotactic Laser Ablation, Stereotactic Radiosurgery and MRI guided laser ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to 20 Jun 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
- Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.
- Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not required.
- The vertebral body site to be treated must be located from T2 to L1
- No more than 3 contiguous or dis-contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.
- Motor strength ≥4 out of 5 in extremity or extremities affected by the level of the spinal cord compression (see section 4 for grading method).
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- ECOG performance status <2 or Karnofsky performance status (KPS) >50
- Life expectancy >3 months.
- Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.
- Signed informed consent.
Who cannot join
- Requires open spinal procedure or a percutaneous procedure without the use of image guidance.
- Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases.
- Unable to tolerate general anesthesia and prone position.
- Unable to undergo MRI scan of the spine.
- Inability to lie flat on a treatment table for >60 minutes.
- Pregnant. (Urine testing must be done no more than 10 days prior to surgery.)
- Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.
- Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength <4/5 in extremity or extremities affected by the level of the spinal cord compression)
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, 1 recruiting
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
RAMONA DAVIS, 3132821753, RDavis18@hfhs.org
REHNUMA NEWAZ, 3139164123, RNewaz1@hfhs.org
About this study
Official title: A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases
The purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve quality of life. We will also assess how effective these combined modes of treatment are in patients with spinal metastasis with an epidural component.
Read the detailed description
Primary Objectives:
- Documenting rate of local control in patients who have received this combined treatment and
- Documenting safety of MRI compatible hardware for MRI based image guidance
- Determining the accuracy of the MRI-based image guidance
Secondary Objectives:
- To determine local control at 1, 3, 6, 9, 18, and 24 months, and to compare to a historical control where patients received only SSRS at these time points and at 12 months.
- To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months
- Calculate decrease in epidural tumor volume (by volumetric measurements using Brain Lab Elements software)
- Calculate increase in thecal sac patency (by volumetric measurements using Brain Lab Elements software and according to Bilsky method
- To determine overall survival at 6, 12, 18, and 24 months.
- To assess changes in muscle strength, location and severity of spinal-related pain, sensory function, ability to ambulate, and neurological grading at 1, 3, 6, 9, 12, 18, and 24 months compared with pretreatment baselines.
- To assess the effect of treatment on quality of life, measured at 1 month and every 3 months after with validated outcome measure tools
- To describe adverse side effects after treatment and to descriptively correlate those effects with radiographic findings, pain control, and quality of life.
- Conditions
- Neoplasm Metastasis, Spinal Cord Diseases, Spinal Cord Compression, Spinal Cord Tumor, Spine Metastases
- Being tested
- Stereotactic Laser Ablation, Stereotactic Radiosurgery, MRI guided laser ablation
- Keywords
- Laser Ablation, Spinal Cord, Minimally Invasive Surgical Procedure, Stereotactic Radiosurgery, Pain Control, Metastasis, Epidural Tumor
- Medical subject headings
- Neoplasm Metastasis, Spinal Cord Diseases, Spinal Cord Compression, Spinal Cord Neoplasms, Agnosia, Epidural Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Laser AblationProcedure or surgery
Also called Thermal laser ablation therapy, Visualase laser ablation therapy
MR Guided laser ablation therapy
Stereotactic RadiosurgeryRadiation
Also called CT guided stereotactic radiosurgery, Stereotactic external beam radiation therapy
Precise delivery of radiation to spinal tumor
MRI guided laser ablationDiagnostic test
Also called Intraoperative MRI
Surgery will take place in intraoperative suite to include operating room and MRI scanner
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery | Experimental | Patients will undergo laser interstitial thermal ablation and CT guided stereotactic radiosurgery via intensity-modulated radiation therapy on different dates within a one to fourteen day window. The order of treatment is at the treating physicians discretion. Receives: Procedure: Stereotactic Laser Ablation; Radiation: Stereotactic Radiosurgery; Diagnostic Test: MRI guided laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Control Rate
Kaplan-Meier estimates will be used.
Measured: up to 24 months
Secondary outcomes (6)
Local Tumor Control
Time to local failure will be monitored continuously using Bayesian method.
Measured: 1, 3, 6, 9, 12, 18, and 24 months
Postoperative response to treatment assessed by MRI
Routine MRI of the spine with and without contrast will be obtained at each follow-up visit. These post-treatment scans will be analyzed and compared to baseline scans for assessment of treatment response and local control. Bilsky grading system will be used.
Measured: 1, 3, 6, 9, 12, 18, and 24 months
Adverse Events
To describe adverse side effects after treatment and descriptively correlate those effects with radiographic findings, pain control, and quality of life.
Measured: up to 24 months
Overall Survival
Kaplan-Meier estimates will be used.
Measured: 6, 12, 18, and 24 months
Changes in symptoms assessed by physical examination
The Physical Exam includes a general exam:(HEENT) Head, Eye, Ear, Nose and Throat evaluation, chest, heart, abdomen and extremities exam. Changes will be compared to baseline measurements. Negative changes will be evaluated by the neurosurgeon and radiation oncologist to determine if the change is related to a local failure or progression of systemic disease. Kaplan-Meier estimates will be used.
Measured: 1, 3, 6, 9, 12, 18, 24 months and annually thereafter
Changes in symptoms assessed by neurological examination
The neurological examination includes: mental status (tested through history taking), cranial nerves (observation of eyes, face, voice, and coordination during history taking and as patient moves about the exam room), motor system (visual inspection, tone, muscle strength and endurance, assigned score of 0-5 for each muscle, a score of 0 would mean no muscular contraction, and a score of 5 would mean movement against full resistance, normal strength), reflexes, sensory system (vibration in toes; pinprick in feet); coordination (truncal stability, fine finger movement, toe tapping, finger-nose-finger, heel-knee-shin), and station and gait (gait including arising from chair without hands, walking on toes, heels, and heel to toe). Kaplan-Meier estimates will be used.
Measured: 1, 3, 6, 9, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start2 Sep 2021
- Primary completion1 Sep 2027 (estimated)
- Study completion20 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label one arm. Unblinded.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Ian Lee, MD, Henry Ford Health System
- Investigators
- Ian Lee, MD, Principal investigator, Henry Ford Health Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023772
- Sponsor's protocol ID
- 14622
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases
- ClinicalTrials.gov ID
- NCT05023772
- Acronym / sponsor ID
- 14622
- Conditions
- Neoplasm Metastasis, Spinal Cord Diseases, Spinal Cord Compression, Spinal Cord Tumor, Spine Metastases
- Keywords
- Laser Ablation, Spinal Cord, Minimally Invasive Surgical Procedure, Stereotactic Radiosurgery, Pain Control, Metastasis, Epidural Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 20 Jun 2028 (estimated)
- First posted
- 27 Aug 2021 (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 purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve quality of life. We will also assess how effective these combined modes of treatment are in patients with spinal metastasis with an epidural component.
Detailed description
Primary Objectives:
- Documenting rate of local control in patients who have received this combined treatment and
- Documenting safety of MRI compatible hardware for MRI based image guidance
- Determining the accuracy of the MRI-based image guidance
Secondary Objectives:
- To determine local control at 1, 3, 6, 9, 18, and 24 months, and to compare to a historical control where patients received only SSRS at these time points and at 12 months.
- To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months
- Calculate decrease in epidural tumor volume (by volumetric measurements using Brain Lab Elements software)
- Calculate increase in thecal sac patency (by volumetric measurements using Brain Lab Elements software and according to Bilsky method
- To determine overall survival at 6, 12, 18, and 24 months.
- To assess changes in muscle strength, location and severity of spinal-related pain, sensory function, ability to ambulate, and neurological grading at 1, 3, 6, 9, 12, 18, and 24 months compared with pretreatment baselines.
- To assess the effect of treatment on quality of life, measured at 1 month and every 3 months after with validated outcome measure tools
- To describe adverse side effects after treatment and to descriptively correlate those effects with radiographic findings, pain control, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label one arm. Unblinded.
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery | Experimental | Procedure: Stereotactic Laser Ablation, Radiation: Stereotactic Radiosurgery, Diagnostic Test: MRI guided laser ablationPatients will undergo laser interstitial thermal ablation and CT guided stereotactic radiosurgery via intensity-modulated radiation therapy on different dates within a one to fourteen day window. The order of treatment is at the treating physicians discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
- Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.
- Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not required.
- The vertebral body site to be treated must be located from T2 to L1
- No more than 3 contiguous or dis-contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.
Key exclusion criteria (8 listed)
- Requires open spinal procedure or a percutaneous procedure without the use of image guidance.
- Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases.
- Unable to tolerate general anesthesia and prone position.
- Unable to undergo MRI scan of the spine.
- Inability to lie flat on a treatment table for >60 minutes.
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 |
|---|---|---|
| Stereotactic Laser AblationAlso: Thermal laser ablation therapy, Visualase laser ablation therapyMR Guided laser ablation therapy | Procedure or surgery | Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery |
| Stereotactic RadiosurgeryAlso: CT guided stereotactic radiosurgery, Stereotactic external beam radiation therapyPrecise delivery of radiation to spinal tumor | Radiation | Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery |
| MRI guided laser ablationAlso: Intraoperative MRISurgery will take place in intraoperative suite to include operating room and MRI scanner | Diagnostic test | Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery |
Primary outcome
Local Tumor Control Rate
Time frame: up to 24 months
Kaplan-Meier estimates will be used.
6 secondary outcomes
Local Tumor Control
Time frame: 1, 3, 6, 9, 12, 18, and 24 months
Postoperative response to treatment assessed by MRI
Time frame: 1, 3, 6, 9, 12, 18, and 24 months
Adverse Events
Time frame: up to 24 months
Overall Survival
Time frame: 6, 12, 18, and 24 months
Changes in symptoms assessed by physical examination
Time frame: 1, 3, 6, 9, 12, 18, 24 months and annually thereafter
Changes in symptoms assessed by neurological examination
Time frame: 1, 3, 6, 9, 12, 18, and 24 months
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Ian Lee, MD principal investigator
Henry Ford Health Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Laser Ablation, Stereotactic Radiosurgery and MRI guided laser ablation in people with Neoplasm Metastasis and Spinal Cord Diseases, run by Henry Ford Health System 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 12 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Jun 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 RAMONA DAVIS (3132821753, RDavis18@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Control Rate (time frame: up to 24 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 3 Jun 2026.