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Sonography-guided Resection of Brain Mass Lesions (SOMALI)

S

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

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)

100 participants in 1 patient group

Surgery
Experimental group
Description:
Ultrasound-guided resection of brain tumors, vascular malformations and hematomas
Treatment:
Device: Sonography

Trial contacts and locations

1

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Central trial contact

Alexander Dmitriev, MD

Data sourced from clinicaltrials.gov

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