Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Clinical Laserthermia Systems AB
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
