MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

Glioblastoma Clinical Trial

— EMITT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596930
• Other study ID #: NL73896.091.20
• Status: Completed
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2021
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 31, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Procedure:
• Laser ablation thermal therapy
The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance

Locations

Country	Name	City	State
Netherlands	Radboud UMC	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	30-days mortality	To assess safety of LITT at our center in patients with irresectable glioblastoma	30 days
Primary	Number of patients with complications	To assess safety of LITT at our center in patients with irresectable glioblastoma	3 months
Primary	Time from inclusion to procedure	To assess feasibility of LITT at our center in patients with irresectable glioblastoma	3 months
Primary	Time from LITT to adjuvant therapy	To assess feasibility of LITT at our center in patients with irresectable glioblastoma	3 months
Primary	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	Overall survival and progression free survival	To assess preliminary data on survival	12 months
Secondary	Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)	To assess preliminary data on quality of life	3 months
Secondary	European Organisation for Research and Treatment of Cancer - BN20 brain module	To assess preliminary data on quality of life	3 months
Secondary	Tumor volume evolution	To assess tumour volume evolution on MRI at 3 months post-operatively	3 months