Sonography-guided Resection of Brain Mass Lesions (SOMALI)

Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Arteriovenous Malformations; Tumor, Brain; Cavernoma; Intracerebral Hematoma
• Intervention / Treatment: Device: Sonography

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Dmitriev, MD; Phone Number: +7 (916) 423-54-08; Email: dmitriev@neurosklif.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 129090
    • Recruiting
    • Sklifosovsky Institute of Emergency Care
    • Contact: Alexander Dmitriev, MD; Phone Number: +7 (916) 423-54-08

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery; Ultrasound-guided resection of brain tumors, vascular malformations and hematomas	Device: Sonography; Surgeon detects brain mass lesion and assesses extent of it's resection with sonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound features of various brain mass lesions in Mair scale (in grades)	Assessment of target visibility, echogenicity, homogeneity and border demarcation in sonography and their comparison to preoperative computed tomography and magnetic resonance imaging	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral complications	Which cerebral complications arose after surgery	From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Extent of resection (in percents)	Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100	Within 48 hours after surgery
Karnofsky performance status (in percents)	Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale	Within 10 days after surgery
Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents)	Sensitivity = true detection of mass lesion / (true detection of mass lesion + inability to detect mass lesion) x 100	Intraoperatively
Sensitivity of intraoperative sonography to detect residual mass lesion compared to postoperative magnetic resonance imaging or computed tomography (in percents)	Sensitivity = true detection of residual mass lesion / (true detection of residual mass lesion + inability to detect residual mass lesion) x 100	Within 48 hours after surgery
Specificity of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)	Specificity = true absence of residual mass lesion / (true absence of residual mass lesion + false detection of residual mass lesion) x 100	Within 48 hours after surgery
Positive predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)	Positive predictive value = true detection of residual mass lesion / (true detection of residual mass lesion + false detection of residual mass lesion) x 100	Within 48 hours after surgery
Negative predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)	Negative predictive value = true absence of residual mass lesion / (true absence of residual mass lesion + inability to detect residual mass lesion) x 100	Within 48 hours after surgery
Accuracy of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)	Accuracy = (true detection of residual mass lesion + true absence of residual mass lesion) / (true detection of residual mass lesion + true absence of residual mass lesion + false detection of residual mass lesion + inability to detect residual mass lesion) x 100	Within 48 hours after surgery
Duration of mass lesion removal (in minutes)	How long did in take to remove mass lesion from starting of it's dissection till final evacuation	Intraoperatively
Differentiation between artefacts and residual lesion (Yes or No)	Possibility of ultrasound differentiation between artefacts and residual lesion	Intraoperatively
Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes)	Only for subcortical or deep-seated mass lesions. How long did in take to reach margin of mass lesion after dural incision using ultrasound-guided needle or ultrasound wire-guided port	Intraoperatively

Collaborators and Investigators

• Sponsor: Sklifosovsky Institute of Emergency Care
• Investigators: Principal Investigator: Alexander Dmitriev, MD, Sklifosovsky Institute of Emergency Care

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: brain tumor; arteriovenous malformation; cavernoma; intraoperative ultrasound; intraoperative sonography; intracerebral hematoma
• Additional Relevant MeSH Terms: Cavernous Sinus Syndromes; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Hemorrhage; Hematologic Diseases; Cardiovascular Abnormalities; Nervous System Neoplasms; Hemostatic Disorders; Hemorrhagic Disorders; Neoplasms, Vascular Tissue; Central Nervous System Neoplasms; Intracranial Hemorrhages; Vascular Malformations; Hemangioma; Congenital Abnormalities; Brain Neoplasms; Cerebral Hemorrhage; Hematoma; Arteriovenous Malformations; Hemangioma, Cavernous
• Other Study ID Numbers: 9g

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No