Status:
COMPLETED
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions
Lead Sponsor:
Clinical Laserthermia Systems AB
Conditions:
Glioblastoma
Eligibility:
All Genders
18-80 years
Phase:
NA
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 sub...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05296122
Start Date
May 12 2022
End Date
October 30 2024
Last Update
January 15 2025
Active Locations (1)
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1
Department of Neurosurgery, Skåne University Hospital
Lund, Sweden, 22185