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

Primary Purpose

Glioblastoma

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Laser ablation thermal therapy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud UMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LITT arm

Arm Description

Patients will be randomized to receive biopsy and LITT (n=10)

Outcomes

Primary Outcome Measures

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
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
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
30-days mortality
To assess safety of LITT at our center in patients with irresectable glioblastoma
Number of patients with complications
To assess safety of LITT at our center in patients with irresectable glioblastoma
Time from inclusion to procedure
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Time from LITT to adjuvant therapy
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
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

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2020
Last Updated
August 8, 2022
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04596930
Brief Title
MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma
Acronym
EMITT
Official Title
MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LITT arm
Arm Type
Experimental
Arm Description
Patients will be randomized to receive biopsy and LITT (n=10)
Intervention Type
Procedure
Intervention Name(s)
Laser ablation thermal therapy
Intervention Description
The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance
Primary Outcome Measure Information:
Title
Inclusion rate of patients meeting the inclusion criteria
Description
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Time Frame
12 months
Title
Number drop out (informed consent)
Description
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Time Frame
30 days
Title
Number of patients with completed follow-up at 3 months
Description
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Time Frame
3 months
Title
30-days mortality
Description
To assess safety of LITT at our center in patients with irresectable glioblastoma
Time Frame
30 days
Title
Number of patients with complications
Description
To assess safety of LITT at our center in patients with irresectable glioblastoma
Time Frame
3 months
Title
Time from inclusion to procedure
Description
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Time Frame
3 months
Title
Time from LITT to adjuvant therapy
Description
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Time Frame
3 months
Title
Ablation of 90 percent of the target lesion in at least 70 percent of patients
Description
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Overall survival and progression free survival
Description
To assess preliminary data on survival
Time Frame
12 months
Title
Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)
Description
To assess preliminary data on quality of life
Time Frame
3 months
Title
European Organisation for Research and Treatment of Cancer - BN20 brain module
Description
To assess preliminary data on quality of life
Time Frame
3 months
Title
Tumor volume evolution
Description
To assess tumour volume evolution on MRI at 3 months post-operatively
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Radboud UMC
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

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