Clinical trial NCT05484245: Sonography-guided Resection of Brain Mass Lesions
Official title: Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor, Brain
Arteriovenous Malformations
Cavernoma
Intracerebral Hematoma
Keywords: intraoperative sonography
intraoperative ultrasound
brain tumor
cavernoma
arteriovenous malformation
intracerebral hematoma
Lead sponsor: Sklifosovsky Institute of Emergency Care
Sponsor class: OTHER_GOV
First posted: 2022-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ultrasound features of various brain mass lesions in Mair scale (in grades)
timeFrame: Intraoperatively
Secondary outcomes:
measure: Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents)
timeFrame: Intraoperatively
measure: Sensitivity of intraoperative sonography to detect residual mass lesion compared to postoperative magnetic resonance imaging or computed tomography (in percents)
timeFrame: Within 48 hours after surgery
measure: Specificity of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
timeFrame: Within 48 hours after surgery
measure: Positive predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
timeFrame: Within 48 hours after surgery
measure: Negative predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
timeFrame: Within 48 hours after surgery
measure: Accuracy of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
timeFrame: Within 48 hours after surgery
measure: Duration of mass lesion removal (in minutes)
timeFrame: Intraoperatively
measure: Extent of resection (in percents)
timeFrame: Within 48 hours after surgery
measure: Differentiation between artefacts and residual lesion (Yes or No)
timeFrame: Intraoperatively
measure: Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes)
timeFrame: Intraoperatively
measure: Karnofsky performance status (in percents)
timeFrame: Within 10 days after surgery
measure: Cerebral complications
timeFrame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sklifosovsky Institute of Emergency Care
Study officials:
affiliation: Sklifosovsky Institute of Emergency Care
name: Alexander Dmitriev, MD
role: PRINCIPAL_INVESTIGATOR
References: