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NCT Number: NCT04596930

MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

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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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud UMC

Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser ablation thermal therapy

Procedure

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

Primary outcomes

  1. Inclusion rate of patients meeting the inclusion criteria

    Time frame: 12 months

    To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial

  2. Number drop out (informed consent)

    Time frame: 30 days

    To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial

  3. Number of patients with completed follow-up at 3 months

    Time frame: 3 months

    To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial

  4. 30-days mortality

    Time frame: 30 days

    To assess safety of LITT at our center in patients with irresectable glioblastoma

  5. Number of patients with complications

    Time frame: 3 months

    To assess safety of LITT at our center in patients with irresectable glioblastoma

  6. Time from inclusion to procedure

    Time frame: 3 months

    To assess feasibility of LITT at our center in patients with irresectable glioblastoma

  7. Time from LITT to adjuvant therapy

    Time frame: 3 months

    To assess feasibility of LITT at our center in patients with irresectable glioblastoma

  8. Ablation of 90 percent of the target lesion in at least 70 percent of patients

    Time frame: 3 months

    To assess feasibility of LITT at our center in patients with irresectable glioblastoma

Secondary outcomes

  1. Overall survival and progression free survival

    Time frame: 12 months

    To assess preliminary data on survival

  2. Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)

    Time frame: 3 months

    To assess preliminary data on quality of life

  3. European Organisation for Research and Treatment of Cancer - BN20 brain module

    Time frame: 3 months

    To assess preliminary data on quality of life

  4. Tumor volume evolution

    Time frame: 3 months

    To assess tumour volume evolution on MRI at 3 months post-operatively

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: EMITT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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