Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

MR-Guided Laser Thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG ® Thermoguide Workstation.

The main purpose with the study is to investigate safety and feasibility of the TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation together with SmartTwist™ MR Hand Drill with the SmartTip™ MR Drill Kit for MR-guided laser thermal ablation of brain lesions.

TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.

Karin Peterson

Peter Siesjö, Prof

This will be an open-label, pilot, exploratory, single centre clinical investigation. This is an early feasibility single arm study. No formal hypothesis is proposed. A total of up to 15 evaluable subjects receiving a non-radical ablation is planned.

The safety and feasibility outcomes will be measured directly post-treatment, 48h and 3 months post-treatment.

A minimal invasive neurosurgical approach with a Magnetic Resonance Imaging (MRI)-based stereotactic guidance system will be utilized for the planning, navigation, intracranial access, placement and confirmation of the Laser applicator prior to ablation.

Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions

Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesion Using the Tranberg® Thermal Therapy System and Tranberg® Thermoguide Workstation

The volume of remaining tumor mass will be assessed by contrast enhanced MRI after MR-Guided laser thermal ablation using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.

The number and severity of adverse events related to the TRANBERG® Laser applicator when used in MR-guided laser thermal ablation of brain lesions

The number and severity of adverse events related to the SmartTwist™ MR HAND DRILL with the SmartTip™ MR Drill Kit when used for intracranial access.

Clinical Laserthermia Systems AB

Symptoms and General Pathology

Nervous System Diseases

Wounds and Injuries

Neoplasm Metastasis

Pain

Spinal Cord Diseases

Spinal Cord Neoplasms

Spinal Cord Compression

Epidural Neoplasms

Neoplasms, Second Primary

Neoplastic Processes

Central Nervous System Diseases

Spinal Cord Injuries

Central Nervous System Neoplasms

Nervous System Neoplasms

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.

Stereotactic Laser Ablation

Precise delivery of radiation to spinal tumor

Stereotactic Radiosurgery

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

MRI guided laser ablation

RAMONA DAVIS

REHNUMA NEWAZ

IAN LEE, MD, FAANS

ADAM ROBIN, MD

MIRA SHAH, MD

SALIM SIDDIQUI, MD,PHD

Ian Lee, MD

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.

Primary Objectives:

1. Documenting rate of local control in patients who have received this combined treatment and
2. Documenting safety of MRI compatible hardware for MRI based image guidance
3. Determining the accuracy of the MRI-based image guidance

Secondary Objectives:

1. 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.
2. 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
3. To determine overall survival at 6, 12, 18, and 24 months.
4. 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.
5. To assess the effect of treatment on quality of life, measured at 1 month and every 3 months after with validated outcome measure tools
6. To describe adverse side effects after treatment and to descriptively correlate those effects with radiographic findings, pain control, and quality of life.

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

A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases

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.

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.

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 to local failure will be monitored continuously using Bayesian method.

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.

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

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions	NCT05296122	Glioblastoma	TRANBERG® laser...	18 Years - 80 Years	Clinical Laserthermia Systems AB
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions	NCT05296122	Glioblastoma	TRANBERG® laser...	18 Years - 80 Years	Clinical Laserthermia Systems AB
Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases	NCT05023772	Neoplasm Metast... Spinal Cord Dis... Spinal Cord Com... Spinal Cord Tum... Spine Metastase...	Stereotactic La... Stereotactic Ra... MRI guided lase...	18 Years -	Henry Ford Health System

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