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

NCT05296122 | Completed

• 1 other identifier: CTP-2021-012
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

Laser Thermotherapy; Magnetic Resonance guidance; Interventional; Thermal ablation; Clearpoint Neuro Navigation; Magnetic Resonance thermometry; Minimal invasive; MRg LITT; TRANBERG; Thermoguide; Stereotactic Laser Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Device and procedure related adverse events

  From Day 1 throughout the study until 3 months

Other Outcomes (1)

• Device performance

  At 3 months after treatment

Study Arms (1)

Single arm

EXPERIMENTAL

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.

Interventions

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.

Single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Laserthermia Systems AB: lead

Study Sites (1)

Department of Neurosurgery, Skåne University Hospital

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Siesjö, Prof

  Department of Neurosurgery, Skåne University Hospital, 22185 Lund,Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 25, 2022
• Study Start: May 12, 2022
• Primary Completion: August 30, 2024
• Study Completion: October 30, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)