Effectiveness of MR-guided LITT Therapy in Irresectable Glioblastoma (EMITT)

NCT05318612 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: NL79202.091.21
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 7

Brief Summary

The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma. Glioblastoma are the most common malignant brain tumors and are, due to their devastating nature and the fact that these tumors occur at a relatively young age (median 59 years), responsible for up to 7% of total life years lost from cancer before the age of 70. The current treatment of glioblastoma consists of maximal safe surgery combined with adjuvant chemoradiation therapy (CRT). However, despite this aggressive treatment, these patients still face a poor prognosis (median overall survival 14.5 - 18.5 months). In addition to that, around 30% of the patients diagnosed with a glioblastoma are not suitable for surgery. These patients miss the benefit of a resection and face an even worse prognosis (median overall survival 5.1 months). The primary aim of this project is to investigate whether laser therapy combined with CRT improves overall survival, without compromising quality of life, in comparison with CRT alone in patients with primary irresectable glioblastoma.

Conditions

Primary Glioblastoma

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Percentage of patients still alive for a given period of time after randomization.

  Depending on which event occurs first: either when a study participant dies or at the end of the trial (61 months).

• Health Related Quality of Life (HR-QoL)

  QoL measured with the QLQ-C30BN20 at 5 months after randomization.

  At 5 months after randomization

Secondary Outcomes (10)

• Costs

  At 1, 2, 3, 4, 5, 6, 12, 18, 30, 42 and 54 months after randomization.

• Ablation rate

  Using the MRI made right after LITT procedure

• Progression Free Survival (PFS)

  During the entire study period, estimated 18 months for each patient

• Disease Specific Survival (DSS)

  During the entire study period, estimated 18 months for each patient

• Complication rate

  During the entire study period, estimated 18 months for each patient

Study Arms (2)

Control group (biopsy group)

OTHER

Standard of care: biopsy + adjuvant treatment

Procedure: Biopsy

Intervention group (LITT group)

EXPERIMENTAL

Biopsy + LITT + adjuvant treatment

Procedure: Laser Interstitial Thermal Therapy (LITT)

Interventions

Laser Interstitial Thermal Therapy (LITT) PROCEDURE

LITT is a minimally invasive neurosurgical procedure in which a laser catheter is placed into the tumor and warms the tumor to such an extent that tumor tissue is destroyed. LITT is performed under MR-guidance.

Intervention group (LITT group)

Biopsy PROCEDURE

A sample of tissue from the tumor is obtained to confirm the diagnosis.

Control group (biopsy group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent, age \>18 years
• Suspected glioblastoma
• Supratentorial localization
• Patient is not amendable for surgical resection as decided by the tumor board
• Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures
• Karnofsky Performance Status (KPS) \>=70

You may not qualify if:

• Contra-indication for general anesthesia or MRI
• Non-glioblastoma diagnosis on pathology analysis
• No final pathology available
• Pregnancy
• Insufficient command of the Dutch language by the patient or a family member, making it impossible to fill in the questionnaires

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch National Health Care Institute: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• UMC Utrecht: collaborator

Study Sites (7)

Amsterdam Medical Center

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Elisabeth Tweesteden Ziekenhuis

Tilburg, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

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MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mark ter Laan, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, open-label randomized controlled trial

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 8, 2022
• Study Start: April 8, 2022
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 10, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (7)