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NCT Number: NCT05484245

Sonography-guided Resection of Brain Mass Lesions

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.

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Key information

Conditions

Tumor, Brain Arteriovenous Malformations Brain Diseases Brain Neoplasms Cardiovascular Abnormalities Cardiovascular Diseases Cavernoma Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Hemorrhage Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hemangioma Hemangioma, Capillary Hemorrhage Intracerebral Hematoma Intracranial Hemorrhages Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Malformations

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sklifosovsky Institute of Emergency Care

Moscow, 129090, Russia

Location status: Recruiting

Location contact

Alexander Dmitriev, MD

CONTACT

+7 (916) 423-54-08

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sonography

Device

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

Primary outcomes

  1. Ultrasound features of various brain mass lesions in Mair scale (in grades)

    Time frame: Intraoperatively

    Assessment of target visibility, echogenicity, homogeneity and border demarcation in sonography and their comparison to preoperative computed tomography and magnetic resonance imaging

Secondary outcomes

  1. Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents)

    Time frame: Intraoperatively

    Sensitivity = true detection of mass lesion / (true detection of mass lesion + inability to detect mass lesion) x 100

  2. Sensitivity of intraoperative sonography to detect residual mass lesion compared to postoperative magnetic resonance imaging or computed tomography (in percents)

    Time frame: Within 48 hours after surgery

    Sensitivity = true detection of residual mass lesion / (true detection of residual mass lesion + inability to detect residual mass lesion) x 100

  3. Specificity of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)

    Time frame: Within 48 hours after surgery

    Specificity = true absence of residual mass lesion / (true absence of residual mass lesion + false detection of residual mass lesion) x 100

  4. Positive predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)

    Time frame: Within 48 hours after surgery

    Positive predictive value = true detection of residual mass lesion / (true detection of residual mass lesion + false detection of residual mass lesion) x 100

  5. Negative predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)

    Time frame: Within 48 hours after surgery

    Negative predictive value = true absence of residual mass lesion / (true absence of residual mass lesion + inability to detect residual mass lesion) x 100

  6. Accuracy of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)

    Time frame: Within 48 hours after surgery

    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

  7. Duration of mass lesion removal (in minutes)

    Time frame: Intraoperatively

    How long did in take to remove mass lesion from starting of it's dissection till final evacuation

  8. Extent of resection (in percents)

    Time frame: Within 48 hours after surgery

    Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

  9. Differentiation between artefacts and residual lesion (Yes or No)

    Time frame: Intraoperatively

    Possibility of ultrasound differentiation between artefacts and residual lesion

  10. Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes)

    Time frame: Intraoperatively

    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

  11. Karnofsky performance status (in percents)

    Time frame: Within 10 days after surgery

    Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale

  12. Cerebral complications

    Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days

    Which cerebral complications arose after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Dmitriev, MD

CONTACT

[email protected]

+7 (916) 423-54-08

Sponsors and collaborators

Lead sponsor

Sklifosovsky Institute of Emergency Care

Other Gov

Registry information

Official study title

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

Acronym: SOMALI

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 2, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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