Sonography-guided Resection of Brain Mass Lesions

NCT ID: NCT05484245

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2027-08-31

Brief Summary

Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.

Detailed Description

Intraoperative sonography is usially used in neurooncology to detect brain tumors and exclude their remnants. A few studies describe it's usage while removing hematomas or vascular malformations. Ultrasound is the only method allowing to observe brain tissue in real time. It is chip and doesn't violate surgical workflow. Main disadvantages of sonography are lengthy learning curve and poorer image quality compared to magnetic resonance imaging. Novel acoustic coupling fluid, contrast-enhanced ultrasound and elastography expanded it's effectiveness. Meanwhile problems of locating of isoechogenic lesions with poor margins and elimination of artefacts are steel actual.

Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.

A surgeon will intraoperatively locate mass lesion and assess extent of it's resection with sonography. Ultrasound scanning will be performed through the same surgical approach or at a distance through enlarged craniotomy, periodically or permanently. To facilitate approach to subcortical and deep small mass lesions ultrasound-guided needle or ultrasound wire-guided port will be used.

Conditions

Tumor, Brain; Arteriovenous Malformations; Cavernoma; Intracerebral Hematoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery

Ultrasound-guided resection of brain tumors, vascular malformations and hematomas

Group Type: EXPERIMENTAL

Sonography

Intervention Type: DEVICE

Surgeon detects brain mass lesion and assesses extent of it's resection with sonography

Interventions

Sonography

Surgeon detects brain mass lesion and assesses extent of it's resection with sonography

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• all intracranial tumors
• cavernomas
• arteriovenous malformations
• spontaneous (non-traumatic) intracerebral hemorrhages
• traumatic intracerebral hemorrhages
• supratentorial localization
• newly diagnosed
• age 18-100 years
• stable hemodynamics

Exclusion Criteria

• rapid cerebral dislocation
• previously performed brain radiotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sklifosovsky Institute of Emergency Care

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alexander Dmitriev

Principal Investigator

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

Site Status: RECRUITING

Countries

Russia

Central Contacts

Alexander Dmitriev, MD

Role: CONTACT

dmitriev@neurosklif.ru

+7 (916) 423-54-08

Facility Contacts

Alexander Dmitriev, MD

Role: primary

+7 (916) 423-54-08

Other Identifiers

9g

Identifier Type: -

Identifier Source: org_study_id