Clinical trial NCT04596930: MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma
Official title: MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Inclusion rate of patients meeting the inclusion criteria
timeFrame: 12 months
measure: Number drop out (informed consent)
timeFrame: 30 days
measure: Number of patients with completed follow-up at 3 months
timeFrame: 3 months
measure: 30-days mortality
timeFrame: 30 days
measure: Number of patients with complications
timeFrame: 3 months
measure: Time from inclusion to procedure
timeFrame: 3 months
measure: Time from LITT to adjuvant therapy
timeFrame: 3 months
measure: Ablation of 90 percent of the target lesion in at least 70 percent of patients
timeFrame: 3 months
Secondary outcomes:
measure: Overall survival and progression free survival
timeFrame: 12 months
measure: Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)
timeFrame: 3 months
measure: European Organisation for Research and Treatment of Cancer - BN20 brain module
timeFrame: 3 months
measure: Tumor volume evolution
timeFrame: 3 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud UMC
Study officials:
References: