MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-22

Study Completion Date

2022-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LITT arm

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

Group Type EXPERIMENTAL

Laser ablation thermal therapy

Intervention Type PROCEDURE

The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance

Interventions

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Laser ablation thermal therapy

The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No