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

Study acronym: EMITT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 10, 2024 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 7 of 7 sites
    v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Minor Site details revised at 4 of 7 sitesv3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 6 to 7
    • Start date changed from estimate of Apr 1, 2022 to Apr 8, 2022
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05318612
Lead Sponsor Radboud University Medical Center
Collaborators: Dutch National Health Care Institute, ZonMw: The Netherlands Organisation for Health Research and Development, UMC Utrecht
Conditions
(from sponsor)
Primary Glioblastoma
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov