MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

Study Overview
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Brief Summary
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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).

Official Title
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MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Randomized Pilot Study

Conditions
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Glioblastoma

Intervention / Treatment
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* Procedure: Laser ablation thermal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria In order to be eligible to participate in the study, a patient must meet all of the following criteria: Informed consent, age >18-year-old Supratentorial localization Maximal volume <=70cc on post-contrast T1 MRI Safe trajectory/trajectories possible for ablation of 70% of the tumour, avoiding eloquent structures or transgression of a ventricle or vessel . Karnofsky Performance Status (KPS) >= 70 Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: Contra-indication for general anaesthesia or MRI Lesion >70cc on post-contrast MRI on the day before intervention. Non-glioblastoma diagnosis as per frozen section analysis Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LITT arm<br>Patients will be randomized to receive biopsy and LITT (n=10) | Procedure: Laser ablation thermal therapy<br>* The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 3 months | 
| 30-days mortality | To assess safety of LITT at our center in patients with irresectable glioblastoma | 30 days | 
| Number of patients with complications | To assess safety of LITT at our center in patients with irresectable glioblastoma | 3 months | 
| Time from inclusion to procedure | To assess feasibility of LITT at our center in patients with irresectable glioblastoma | 3 months | 
| Time from LITT to adjuvant therapy | To assess feasibility of LITT at our center in patients with irresectable glioblastoma | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival and progression free survival | To assess preliminary data on survival | 12 months | 
| Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome) | To assess preliminary data on quality of life | 3 months | 
| European Organisation for Research and Treatment of Cancer - BN20 brain module | To assess preliminary data on quality of life | 3 months | 
| Tumor volume evolution | To assess tumour volume evolution on MRI at 3 months post-operatively | 3 months |