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

Sponsor

Clinical Laserthermia Systems AB (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05296122

Collaborator

(none)

Enrollment

Location

Arm

9.6

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 5 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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	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.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

May 12, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm 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. 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.

Arm

Intervention/Treatment

Experimental: Single arm

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Device and procedure related adverse events [From Day 1 throughout the study until 3 months]
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.

Other Outcome Measures

Device performance [At 3 months after treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Lesions eligible for Laser Interstitial ThermoTherapy (LITT), target tumor ≤3 cm in diameter
Age ≥ 18 and < 80 years
Ability to undergo contrast-enhanced Computed Tomography (CT), Positron Emission Tomography (PET)-CT and contrast-enhanced MRI.
Negative Covid-19 Polymerase Chain Reaction (PCR) test
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
Subject has received minimum one dose of European Medicines Agency (EMA) approved Covid-19 vaccine
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