Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tumor, Brain
- Sponsor
- Sklifosovsky Institute of Emergency Care
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Ultrasound features of various brain mass lesions in Mair scale (in grades)
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Alexander Dmitriev
Principal Investigator
Sklifosovsky Institute of Emergency Care
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
Outcomes
Primary Outcomes
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
- Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents)(Intraoperatively)
- Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes)(Intraoperatively)
- Duration of mass lesion removal (in minutes)(Intraoperatively)
- Differentiation between artefacts and residual lesion (Yes or No)(Intraoperatively)
- Negative predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)(Within 48 hours after surgery)
- Sensitivity of intraoperative sonography to detect residual mass lesion compared to postoperative magnetic resonance imaging or computed tomography (in percents)(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)(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)(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)(Within 48 hours after surgery)
- Extent of resection (in percents)(Within 48 hours after surgery)
- Karnofsky performance status (in percents)(Within 10 days after surgery)
- Cerebral complications(From admission to intensive care unit after surgery till hospital discharge, up to 365 days)