Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas

NCT ID: NCT05470374

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2027-08-31

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.

Conditions

Non-enhancing Cerebral Gliomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ultrasound

Glioma resection with intraoperative sonography

Group Type: EXPERIMENTAL

Intraoperative sonography

Intervention Type: PROCEDURE

ultrasound scanning of brain to search tumor remnants

Non-ultrasound

Glioma resection without intraoperative sonography

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intraoperative sonography

ultrasound scanning of brain to search tumor remnants

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sklifosovsky Institute of Emergency Care

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alexander Dmitriev

Neurosurgeon, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Dmitriev, MD

Role: PRINCIPAL_INVESTIGATOR

Sklifosovsky Institute of Emergency Care

Locations

Sklifosovsky Institute of Emergency Care

Moscow, , Russia

Countries

Russia

Other Identifiers

9

Identifier Type: -

Identifier Source: org_study_id