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Completed

NCT Number: NCT05296122

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

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery, Skåne University Hospital

Lund, 22185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.
  • ≥3 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

Treatment and study plan

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

Device

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 outcomes

  1. Device and procedure related adverse events

    Time frame: 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 outcomes

  1. Device and procedure related adverse events

    Time frame: 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 outcomes

  1. Device performance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clinical Laserthermia Systems AB

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2022
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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