Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas (SONOGLIO)

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

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

Study Overview

• Status: Suspended
• Conditions: Non-enhancing Cerebral Gliomas
• Intervention / Treatment: Procedure: Intraoperative sonography

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 129090
    • Sklifosovsky Institute of Emergency Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 brainstem
• previously performed radiotherapy, chemotherapy or immunotherapy
• planned supratotal tumor resection until neurophysiologically revealed eloquent areas

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
Cerebral complications	Which cerebral complications arose after surgery	From admission to intensive care unit after surgery till hospital discharge, up to 365 days
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
Karnofsky Performance status in percents	Assesses patients' possibilities to self-service	within 10 days after surgery

Collaborators and Investigators

• Sponsor: Sklifosovsky Institute of Emergency Care
• Investigators: Principal Investigator: Alexander Dmitriev, MD, Sklifosovsky Institute of Emergency Care

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No