Clinical trial · Interventional
Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.
Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
- 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)
The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR) without causing new neurological deficits1-8. Intraoperative navigated high resolution ultrasound (US) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. The aim of this study was to investigate whether intraoperative guided surgery leads to a higher rate of GTR, when compared with standard non-ultrasound guided surgery.
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 |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultrasound guided surgery. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ultrasound
- description
- ultrasound navigation guided surgery.
- interventionNames
- Procedure: ultrasound guided surgery.
- type
- NO_INTERVENTION
- label
- Non-ultrasound
- description
- standard surgery without ultrasound guidance.
Primary outcomes (1)
- measure
- Gross total resection (Yes or No)
- timeFrame
- within 48 hours after surgery
- description
- Gross-total resection (yes vs. no): No residual contrast enhancement on post-operative MRI scans; 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals of 18 years or older * Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma * KPS ≥ 60 * Preoperative intention to perform gross-total resection of the enhancing tumor * Written informed consent conform ICH-GCP Exclusion Criteria: * Tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection * Multifocal contrast enhancing lesions * Pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke) * Inability to give consent because of dysphasia or language barrier
References
Publications (1)
- DERIVEDIncekara F, Smits M, Dirven L, Bos EM, Balvers RK, Haitsma IK, Schouten JW, Vincent AJPE. Intraoperative B-Mode Ultrasound Guided Surgery and the Extent of Glioblastoma Resection: A Randomized Controlled Trial. Front Oncol. 2021 May 19;11:649797. doi: 10.3389/fonc.2021.649797. eCollection 2021. PMID 34094939