Sonography-guided Resection of Brain Mass Lesions (SOMALI)

Sklifosovsky Institute of Emergency Care

Status: Enrolling

Conditions: Cavernoma; Arteriovenous Malformations; Intracerebral Hematoma; Tumor, Brain

Treatments: Device: Sonography

Study type: Interventional

Funder types: Other

Identifiers

NCT05484245

9g

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Surgery

Experimental group

Description:

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

Treatment:

Device: Sonography