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Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases

Primary Purpose

Neoplasm Metastasis, Spinal Cord Diseases, Spinal Cord Compression

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Laser Ablation

Stereotactic Radiosurgery

MRI guided laser ablation

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Laser Ablation, Spinal Cord, Minimally Invasive Surgical Procedure, Stereotactic Radiosurgery, Pain Control, Metastasis, Epidural Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
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.

Exclusion Criteria:

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)

Sites / Locations

Henry Ford HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery

Arm Description

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.

Outcomes

Primary Outcome Measures

Local Tumor Control Rate

Kaplan-Meier estimates will be used.

Secondary Outcome Measures

Local Tumor Control

Time to local failure will be monitored continuously using Bayesian method.

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.

Adverse Events

To describe adverse side effects after treatment and descriptively correlate those effects with radiographic findings, pain control, and quality of life.

Overall Survival

Kaplan-Meier estimates will be used.

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.

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.

Full Information

NCT ID

NCT05023772

First Posted

July 2, 2021

Last Updated

September 13, 2023

Sponsor

Henry Ford Health System

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT05023772

Brief Title

Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 2, 2021 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

Collaborators

Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open Label one arm. Unblinded.

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Stereotactic Laser Ablation

Other Intervention Name(s)

Thermal laser ablation therapy, Visualase laser ablation therapy

Intervention Description

MR Guided laser ablation therapy

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Radiosurgery

Other Intervention Name(s)

CT guided stereotactic radiosurgery, Stereotactic external beam radiation therapy

Intervention Description

Precise delivery of radiation to spinal tumor

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI guided laser ablation

Other Intervention Name(s)

Intraoperative MRI

Intervention Description

Surgery will take place in intraoperative suite to include operating room and MRI scanner

Primary Outcome Measure Information:

Title

Local Tumor Control Rate

Description

Kaplan-Meier estimates will be used.

Time Frame

up to 24 months

Secondary Outcome Measure Information:

Title

Local Tumor Control

Description

Time to local failure will be monitored continuously using Bayesian method.

Time Frame

1, 3, 6, 9, 12, 18, and 24 months

Title

Postoperative response to treatment assessed by MRI

Description

Time Frame

1, 3, 6, 9, 12, 18, and 24 months

Title

Adverse Events

Description

To describe adverse side effects after treatment and descriptively correlate those effects with radiographic findings, pain control, and quality of life.

Time Frame

up to 24 months

Title

Overall Survival

Description

Kaplan-Meier estimates will be used.

Time Frame

6, 12, 18, and 24 months

Title

Changes in symptoms assessed by physical examination

Description

Time Frame

1, 3, 6, 9, 12, 18, 24 months and annually thereafter

Title

Changes in symptoms assessed by neurological examination

Description

Time Frame

1, 3, 6, 9, 12, 18, and 24 months

Other Pre-specified Outcome Measures:

Title

Measuring Quality of life (QOL) assessed by Spine Tumor Survey (MDASI-SP)

Description

We are measuring quality of life with the Spine Tumor Survey that will be assessed during each follow up Clinic visit. The patient survey will be assessed to measure postoperative response to treatment.

Time Frame

baseline and 1, 3, 6, 9, 12, 18, and 24 months

Title

Measuring Quality of life (QOL) assessed by Health Survey (SF-36)

Description

We are measuring quality of life with the Health Survey that will be assessed during each follow up Clinic visit. The participants are asked questions that measure eight health domains to assess physical and mental health. Physical health-related domains include: General health, Physical Functioning, Role Physical, and Body Pain. Mental health-related scales include Vitality, Social Functioning, Role Emotional, and Mental Health. A 3 and 5 point Likert scale is used in the survey. Two summary scores of the physical and mental health using weighted means of the eight domains. Descriptive statistics will be used to summarize pain relief and quality of life at each follow up visit, which will be the changes in scores from baseline to each assessment visit. Time to maximum pain relief will be the time from the day of thermal ablation until the lowest pain score for average pain after radiotherapy.

Time Frame

baseline and 1, 3, 6, 9, 12, 18, and 24 months

Title

Measuring Quality of life (QOL) assessed by Brief Pain Inventory Survey (BPI)

Description

We are measuring quality of life with the Brief Pain Inventory Survey that will be assessed during each follow up Clinic visit. The patient survey will be assessed to measure postoperative response to treatment. Participants are asked to assess the severity of pain and the impact of pain on daily functions. Severity of pain, including the pain location, worst pain in the last 24 hours, least pain in the last 24 hours, pain on average and pain right now. Range 0-10: a score of 0 would mean no pain and a score of 10 means the pain is as bad as you can imagine. Pain medications, amount of pain relief in the past 24 hours, and impact of pain on daily function, including general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life, and range 0-10.

Time Frame

baseline and 1, 3, 6, 9, 12, 18, and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). 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. Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

RAMONA DAVIS

Phone

3132821753

RDavis18@hfhs.org

First Name & Middle Initial & Last Name or Official Title & Degree

REHNUMA NEWAZ

Phone

3139164123

RNewaz1@hfhs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian Lee, MD

Organizational Affiliation

Henry Ford Health Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

RAMONA DAVIS

Phone

313-282-1753

RDavis18@hfhs.org

First Name & Middle Initial & Last Name & Degree

REHNUMA NEWAZ

Phone

3139164123

RNewaz1@hfhs.org

First Name & Middle Initial & Last Name & Degree

IAN LEE, MD, FAANS

First Name & Middle Initial & Last Name & Degree

ADAM ROBIN, MD

First Name & Middle Initial & Last Name & Degree

MIRA SHAH, MD

First Name & Middle Initial & Last Name & Degree

SALIM SIDDIQUI, MD,PHD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases

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