Objective: In preparation of a randomized controlled trial, the investigators aim to assess pilot data on technical feasibility and safety of laser interstitial thermal therapy (LITT) at Radboud University Medical centre and to assess practical feasibility of a randomized study in patients with primary irresectable glioblastoma, as compared with standard of care. Study design: Prospective randomized pilot study. Randomization stopped (amendment September 2nd, 2021), Study population: 20 patients aged \>= 18 with radiologically suspected diagnosis of primary glioblastoma and contra-indication for surgical resection. Intervention: Patients will be randomized to receive either (i) biopsy and LITT (n=10) or (ii) biopsy alone (n=10).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance
Radboud UMC
Nijmegen, Netherlands
Inclusion rate of patients meeting the inclusion criteria
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Time frame: 12 months
Number drop out (informed consent)
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Time frame: 30 days
Number of patients with completed follow-up at 3 months
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Time frame: 3 months
30-days mortality
To assess safety of LITT at our center in patients with irresectable glioblastoma
Time frame: 30 days
Number of patients with complications
To assess safety of LITT at our center in patients with irresectable glioblastoma
Time frame: 3 months
Time from inclusion to procedure
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Time frame: 3 months
Time from LITT to adjuvant therapy
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Time frame: 3 months
Ablation of 90 percent of the target lesion in at least 70 percent of patients
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Time frame: 3 months
Overall survival and progression free survival
To assess preliminary data on survival
Time frame: 12 months
Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)
To assess preliminary data on quality of life
Time frame: 3 months
European Organisation for Research and Treatment of Cancer - BN20 brain module
To assess preliminary data on quality of life
Time frame: 3 months
Tumor volume evolution
To assess tumour volume evolution on MRI at 3 months post-operatively
Time frame: 3 months
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