Status:
ACTIVE_NOT_RECRUITING
Effectiveness of MR-guided LITT Therapy in Irresectable Glioblastoma (EMITT)
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch National Health Care Institute
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Primary Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tum...
Detailed Description
RATIONALE: Glioblastoma (GBM) is the most common primary brain tumor with about 1000 new patients facing this diagnosis each year in the Netherlands alone. It is also one of the most devastating malig...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT05318612
Start Date
April 8 2022
End Date
October 31 2027
Last Update
April 10 2024
Active Locations (7)
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1
Amsterdam Medical Center
Amsterdam, Netherlands
2
University Medical Center Groningen
Groningen, Netherlands
3
Maastricht University Medical Center
Maastricht, Netherlands
4
Radboud University Medical Center
Nijmegen, Netherlands