Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas

Not Applicable

Suspended

• Conditions: Non-enhancing Cerebral Gliomas
• Interventions: Procedure: Intraoperative sonography

• Registration Number: NCT05470374
• Lead Sponsor: Sklifosovsky Institute of Emergency Care

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-22
• Study Start: 2022-09-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Intraoperative sonography	Glioma resection with intraoperative sonography

Primary Outcome Measures

Name	Time	Method
Extent of resection in percents	within 48 hours after surgery	Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sklifosovsky Institute of Emergency Care; 🇷🇺 Moscow, Russian Federation