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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glioblastoma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lesions eligible for Laser Interstitial ThermoTherapy (LITT), target tumor ≤10cc in volume Age ≥ 18 and < 80 years Ability to undergo contrast-enhanced Computed Tomography (CT), Positron Emission Tomography (PET)-CT and contrast-enhanced MRI. Women of childbearing potential must have a negative pregnancy test. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 Progression of a World Health Organization (WHO) grade IV recurrent glioblastoma, confirmed by magnetic resonance imaging according to Response Assessment in Neuro-Oncology (RANO) criteria. ≥6 months since last radiotherapy of the brain Supratentorial tumor localization with or without prior surgery for recurrence. Life expectancy of ≥3 months The subject reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments. Anticipated compliance with treatment and follow-up Exclusion Criteria: Subject contraindicated for MRI, including subjects who may have contraindications due to implanted medical devices Subject evaluated not to be fit for surgery due to liver/kidney/other organ dysfunction verified by laboratory tests Identified intratumoral cystic or haemorrhagic transformation in target tumor Known bleeding disorder ECOG performance status of >2 Previous (within 30 days prior to enrollment / randomization) and concurrent treatment during the treatment phase with other investigational drug/s or device/s Pregnancy or breastfeeding The subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation The subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason. Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>MR-Guided Laser Thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG ® Thermoguide Workstation. | Device: TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device and procedure related adverse events | The number and severity of adverse events related to the TRANBERG® Laser applicator when used in MR-guided laser thermal ablation of brain lesions | From Day 1 throughout the study until 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device and procedure related adverse events | 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. | From Day 1 throughout the study until 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Therapy, Magnetic Resonance guidance, Interventional, Thermal ablation, Clearpoint Neuro Navigation, Magnetic Resonance thermometry, Minimal invasive, MRg LITT, TRANBERG, Thermoguide