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

NCT ID: NCT05296122

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2024-10-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Single arm

MR-Guided Laser Thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG ® Thermoguide Workstation.

Group Type: EXPERIMENTAL

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 Type: 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.

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Laserthermia Systems AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Siesjö, Prof

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Neurosurgery, Skåne University Hospital

Lund, , Sweden

Countries

Sweden

Other Identifiers

CTP-2021-012

Identifier Type: -

Identifier Source: org_study_id