Sonography-guided Resection of Brain Mass Lesions

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Sonography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Extent of resection (in percents) | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 | Within 48 hours after surgery | 
| 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 | 
| Karnofsky performance status (in percents) | Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale | Within 10 days after surgery | 
| Cerebral complications | Which cerebral complications arose after surgery | From admission to intensive care unit after surgery till hospital discharge, up to 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative sonography, intraoperative ultrasound, brain tumor, cavernoma, arteriovenous malformation, intracerebral hematoma