Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas

Study Overview
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Brief Summary
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The purpose of the study is to determine whether intraoperative ultrasound guided resection of glioma without contrast enhancement in magnetic resonance imaging can achieve higher extent of resection than surgery without intraoperative sonography

Detailed Description
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Gliomas, not enhancing contrast agent in magnetic resonance imaging (MRI), are usually low-grade gliomas. They rarely show intraoperative fluorescence using 5-aminolevulinic acid or fluorescein. Intraoperative high-field MRI, sonography and navigation are the only ways to assess extent of their resection during surgery. MRI is the gold standard, but interrupts surgical workflow and only few hospitals are equipped with device like that. Navigation eventually looses it's precision due to brainshift. Ultrasound allows assess tumor remnants in real time but has worse imaging quality. Currently no randomized trials published their results about efficiency of intraoperative sonography in removing low-grade gliomas. Objective of the study is to determine whether intraoperative ultrasound guided resection of non-enhancing gliomas can achieve higher extent of resection than surgery without intraoperative sonography. Participants of the study will be randomly operated with and without intraoperative ultrasound. Extent of resection will be assessed in postoperative MRI by blinded radiologists.

Official Title
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Intraoperative Sonographically Guided Resection of Gliomas Not Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial

Conditions
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Non-enhancing Cerebral Gliomas

Intervention / Treatment
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* Procedure: Intraoperative sonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: single supratentorial gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas) newly diagnosed previously untreated Karnofsky Performance Status 60-100% age 18-79 years performed magnetic resonance imaging with contrast enhancement Exclusion Criteria: glioma spreading to basal ganglia or brainstem previously performed radiotherapy, chemotherapy or immunotherapy planned supratotal tumor resection until neurophysiologically revealed eloquent areas

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br>Glioma resection with intraoperative sonography | Procedure: Intraoperative sonography<br>* ultrasound scanning of brain to search tumor remnants<br>|
| No Intervention: Non-ultrasound<br>Glioma resection without intraoperative sonography | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of resection in percents | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 | within 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross total resection (Yes or No) | Gross total resection is a total removal of tumor (or 100 percents extent of resection) | within 48 hours after surgery | 
| Motor function (in grades) | Motor function is assessed in Medical Research Council scale | within 10 days after surgery | 
| Speech function (in grades) | Speech function is assessed in Hendrix scale (2017) | within 10 days after surgery | 
| Karnofsky Performance status in percents | Assesses patients' possibilities to self-service | within 10 days after surgery | 
| Cerebral complications | Which cerebral complications arose after surgery | From admission to intensive care unit after surgery till hospital discharge, up to 365 days |