Clinical trial NCT05296122: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Clinical Laserthermia Systems AB
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Device and procedure related adverse events
timeFrame: From Day 1 throughout the study until 3 months
Secondary outcomes:
measure: Device and procedure related adverse events
timeFrame: From Day 1 throughout the study until 3 months
Other outcomes:
measure: Device performance
timeFrame: At 3 months after treatment
Locations:
city: Lund
country: Sweden
facility: Department of Neurosurgery, Skåne University Hospital
Study officials:
affiliation: Department of Neurosurgery, Skåne University Hospital, 22185 Lund,Sweden
name: Peter Siesjö, Prof
role: PRINCIPAL_INVESTIGATOR
References: