Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2020-08-01

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Glioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Gross total resection (yes/no) on post-operative T1 postcontrast MRI scans will be evaluated by a neuroradiologist who is blinded for the treatment arm.

Study Groups

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Ultrasound

ultrasound navigation guided surgery.

Group Type EXPERIMENTAL

ultrasound guided surgery.

Intervention Type PROCEDURE

during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.

Non-ultrasound

standard surgery without ultrasound guidance.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ultrasound guided surgery.

during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No