Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions
Primary Purpose
Glioblastoma
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.
Sponsored by
About this trial
This is an interventional device feasibility trial for Glioblastoma focused on measuring Laser Therapy, Magnetic Resonance guidance, Interventional, Thermal ablation, Clearpoint Neuro Navigation, Magnetic Resonance thermometry, Minimal invasive, MRg LITT, TRANBERG, Thermoguide
Eligibility Criteria
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
Sites / Locations
- Department of Neurosurgery, Skåne University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
MR-Guided Laser Thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG ® Thermoguide Workstation.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05296122
First Posted
February 15, 2022
Last Updated
May 2, 2023
Sponsor
Clinical Laserthermia Systems AB
1. Study Identification
Unique Protocol Identification Number
NCT05296122
Brief Title
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions
Official Title
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesion Using the Tranberg® Thermal Therapy System and Tranberg® Thermoguide Workstation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Laserthermia Systems AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Laser Therapy, Magnetic Resonance guidance, Interventional, Thermal ablation, Clearpoint Neuro Navigation, Magnetic Resonance thermometry, Minimal invasive, MRg LITT, TRANBERG, Thermoguide
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
MR-Guided Laser Thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG ® Thermoguide Workstation.
Intervention Type
Device
Intervention Name(s)
TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Device and procedure related adverse events
Description
The number and severity of adverse events related to the TRANBERG® Laser applicator when used in MR-guided laser thermal ablation of brain lesions
Time Frame
From Day 1 throughout the study until 3 months
Secondary Outcome Measure Information:
Title
Device and procedure related adverse events
Description
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.
Time Frame
From Day 1 throughout the study until 3 months
Other Pre-specified Outcome Measures:
Title
Device performance
Description
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.
Time Frame
At 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Peterson
Phone
+46702690103
Email
karin.peterson@clinicallaser.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Siesjö, Prof
Organizational Affiliation
Department of Neurosurgery, Skåne University Hospital, 22185 Lund,Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery, Skåne University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Peterson
Phone
+46702690103
Email
karin.peterson@clinicallaser.se
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions
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