Clinical trial · Interventional
LITT for Ultra-early GBM Recurrence
Laser Interstitial Thermal Therapy for Ultra-Early, Pre-Radiotherapy Glioblastoma Recurrence
- 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)
Glioblastoma (GBM) remains aggressive despite standard therapy (surgery (CRET) + RT/CT). Over 40% of patients develop recurrence between surgery and pre-RT MRI, with median overall survival (OS) of 13.3m and 24.4m for patients with and without recurrence in pre-RT MRI, respectively. Reoperation is avoided as it delays adjuvant therapy. LITT offers a minimally invasive alternative that may: * Treat recurrence without delaying RT/CT * Potentially sensitize tumors to subsequent therapy This study tests if LITT can be practically integrated within the critical 1-week window between pre-RT MRI and radiotherapy initiation, maintaining the adjuvant schedule.
Conditions
Conditions (2)
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 - Category | — | UNRESOLVED | — |
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LITT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- LITT Group
- description
- Patients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT
- interventionNames
- Device: LITT
- type
- NO_INTERVENTION
- label
- Control Group 1 ("No recurrence")
- description
- Patients with no recurrence on pre-RT MRI, proceeding directly to RT.
- type
- NO_INTERVENTION
- label
- Control Group 2 ("No LITT")
- description
- Patients with recurrence but ineligible for LITT, proceeding to another resection or to RT without laser therapy.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed glioblastoma, IDH-wildtype, regardless of MGMT status * ≥18 years of age * CRET * Karnofsky Performance Status (KPS) ≥70 * No contra-indication for radio-chemotherapy * Scheduled for adjuvant radio-chemotherapy at University Hospital of Bern * Able to provide informed consent * No contra-indication for LITT * No pregnancy or active breast-feeding * No known coagulopathy independent of medication * No dissemination or multifocal disease * Patients lacking capacity to consent or considered vulnerable (e.g., minors, those under legal protection) are not included. Exclusion Criteria:
References
Publications (8)
- BACKGROUNDTerrapon APR, Zattra CM, Voglis S, Velz J, Vasella F, Akeret K, Held U, Schiavolin S, Bozinov O, Ferroli P, Broggi M, Sarnthein J, Regli L, Neidert MC. Adverse Events in Neurosurgery: The Novel Therapy-Disability-Neurology Grade. Neurosurgery. 2021 Jul 15;89(2):236-245. doi: 10.1093/neuros/nyab121. PMID 33887774
- BACKGROUNDSchaff LR, Mellinghoff IK. Glioblastoma and Other Primary Brain Malignancies in Adults: A Review. JAMA. 2023 Feb 21;329(7):574-587. doi: 10.1001/jama.2023.0023. PMID 36809318
- BACKGROUNDStupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330. PMID 15758009
- BACKGROUNDWaqar M, Roncaroli F, Lehrer EJ, Palmer JD, Villanueva-Meyer J, Braunstein S, Hall E, Aznar M, De Witt Hamer PC, D'Urso PI, Trifiletti D, Quinones-Hinojosa A, Wesseling P, Borst GR. Rapid early progression (REP) of glioblastoma is an independent negative prognostic factor: Results from a systematic review and meta-analysis. Neurooncol Adv. 2022 Jun 4;4(1):vdac075. doi: 10.1093/noajnl/vdac075. eCollection 2022 Jan-Dec. PMID 35769410
- BACKGROUNDMcGrath K, Frain M, Hey G, Rahman M. Complications following laser interstitial thermal therapy: a review. Neurochirurgie. 2025 Jan;71(1):101604. doi: 10.1016/j.neuchi.2024.101604. Epub 2024 Oct 23. PMID 39413572
- BACKGROUNDRangwala HS, Shafique MA, Mustafa MS, Kumar R, Devi J, Rangwala BS, Ali SMS, Raja A, Iqbal J, Ali M, Haseeb A. Evaluating efficacy and safety of laser interstitial thermal therapy in patients with newly diagnosed and recurrent glioblastoma: a systematic review and meta-analysis. Neurosurg Rev. 2024 Nov 12;47(1):846. doi: 10.1007/s10143-024-03077-6.