Clinical trial NCT03531333: Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.
Official title: Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Keywords: Glioma, intraoperative ultrasound, gross total resection, quality of life
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Coolsingel
First posted: 2018-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.

The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Study design:

The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.

Study population:

Fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan.

Intervention:

The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .

Main study parameters/endpoints:

* Gross total resection (yes/no)
* Extent of resection (%)
* Neurological outcome (Karnofsky Performance Status)
* Quality of Life (EORTC QLQ-C30 and QLQ-BN20 quality of life questionnaire)
* Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
* Adverse events (classified according to the US National Cancer Institute common toxicity criteria version 4.0)
* Survival time (days)

Eligibility criteria: 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

Primary outcomes:
measure: Gross total resection (Yes or No)
timeFrame: within 48 hours after surgery
Secondary outcomes:
measure: Extent of resection (%)
timeFrame: within 48 hours after surgery
measure: Neurological outcome (Karnofsky Performance status)
timeFrame: within 1 week after surgery
measure: Quality of Life (QLQ C30 questionnaires)
timeFrame: 1, 3 and 6 months after surgery
measure: Quality of Life (QLQ BN20 questionnaires)
timeFrame: 1, 3 and 6 months after surgery
measure: Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
timeFrame: 1 month after surgery
measure: Survival (time in days)
timeFrame: status will be checked 15 months after surgery
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References:
citation: Incekara 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.