Clinical trial · Interventional
MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma
MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Randomized Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser ablation thermal therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LITT arm
- description
- Patients will be randomized to receive biopsy and LITT (n=10)
- interventionNames
- Procedure: Laser ablation thermal therapy
Primary outcomes (8)
- measure
- Inclusion rate of patients meeting the inclusion criteria
- timeFrame
- 12 months
- description
- To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
- measure
- Number drop out (informed consent)
- timeFrame
- 30 days
- description
- To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDViozzi I, Overduin CG, Rijpma A, Rovers MM, Laan MT. MR-guided LITT therapy in patients with primary irresectable glioblastoma: a prospective, controlled pilot study. J Neurooncol. 2023 Sep;164(2):405-412. doi: 10.1007/s11060-023-04371-x. Epub 2023 Jul 28. PMID 37505379