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

Not Applicable

Completed

• Conditions: Glioblastoma
• Interventions: 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.

• Registration Number: NCT05296122
• Lead Sponsor: Clinical Laserthermia Systems AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-25
• Study Start: 2022-05-12
• Primary Completion: 2024-08-30
• Study Completion: 2024-10-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Lesions eligible for Laser Interstitial ThermoTherapy (LITT), target tumor ≤10cc in volume
2. Age ≥ 18 and < 80 years
3. Ability to undergo contrast-enhanced Computed Tomography (CT), Positron Emission Tomography (PET)-CT and contrast-enhanced MRI.
4. Women of childbearing potential must have a negative pregnancy test.
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
6. Primary glioblastoma/astrocytoma WHO grade IV confirmed by 1)Magnetic Resonance Imaging according to RANO citera and 2)Frozen section biosy diagnosis, and considered not suitable for open surgery or other primary treatment, or Recurrent glioblastoma/astrocytoma WHO grade IV confirmed by Magnetic Resonance Imaging according to RANO criteria.
7. ≥3 months since last radiotherapy of the brain
8. Supratentorial tumor localization with or without prior surgery for recurrence.
9. Life expectancy of ≥3 months
10. The subject reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments.
11. Anticipated compliance with treatment and follow-up

Exclusion Criteria

1. Subject contraindicated for MRI, including subjects who may have contraindications due to implanted medical devices
2. Subject evaluated not to be fit for surgery due to liver/kidney/other organ dysfunction verified by laboratory tests
3. Identified intratumoral cystic or haemorrhagic transformation in target tumor
4. Known bleeding disorder
5. ECOG performance status of >2
6. Previous (within 30 days prior to enrollment / randomization) and concurrent treatment during the treatment phase with other investigational drug/s or device/s
7. Pregnancy or breastfeeding
8. The subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
9. The subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
10. Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.	MR-Guided Laser Thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG ® Thermoguide Workstation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Neurosurgery, Skåne University Hospital; 🇸🇪 Lund, Sweden