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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05296122
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Clinical Laserthermia Systems AB
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Peter Siesjö, Prof
Principal Investigator Affiliation	Department of Neurosurgery, Skåne University Hospital, 22185 Lund,Sweden
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Sweden
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Experimental: Single arm

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

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.

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.

Contact a Trial Team

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International Sites

Lund, Sweden

Status

Recruiting

Address

Department of Neurosurgery, Skåne University Hospital

Lund, , 22185

Site Contact

Karin Peterson

[email protected]

+46702690103

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