Glioblastoma
Conditions
Brief summary
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).
Interventions
PROCEDURELaser ablation thermal therapy
The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ablation of 90 percent of the target lesion in at least 70 percent of patients | 3 months | To assess feasibility of LITT at our center in patients with irresectable glioblastoma |
| 30-days mortality | 30 days | To assess safety of LITT at our center in patients with irresectable glioblastoma |
| Number of patients with complications | 3 months | To assess safety of LITT at our center in patients with irresectable glioblastoma |
| Time from inclusion to procedure | 3 months | To assess feasibility of LITT at our center in patients with irresectable glioblastoma |
| Time from LITT to adjuvant therapy | 3 months | To assess feasibility of LITT at our center in patients with irresectable glioblastoma |
| Number drop out (informed consent) | 30 days | To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial |
| Inclusion rate of patients meeting the inclusion criteria | 12 months | To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial |
| Number of patients with completed follow-up at 3 months | 3 months | To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome) | 3 months | To assess preliminary data on quality of life |
| European Organisation for Research and Treatment of Cancer - BN20 brain module | 3 months | To assess preliminary data on quality of life |
| Tumor volume evolution | 3 months | To assess tumour volume evolution on MRI at 3 months post-operatively |
| Overall survival and progression free survival | 12 months | To assess preliminary data on survival |
Countries
Netherlands
Outcome results
None listed