MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma (EMITT)

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

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 Overview

• Status: Completed
• Conditions: Glioblastoma
• Intervention / Treatment: Procedure: Laser ablation thermal therapy

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboud UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Actual): February 11, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: NL73896.091.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No