Sonography-guided Resection of Brain Mass Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sonography.
- Who it may be relevant to
- Registry conditions: Tumor, Brain, Arteriovenous Malformations, Cavernoma, Intracerebral Hematoma. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial
Overview
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.
Interventions
- Device Sonography
Surgeon detects brain mass lesion and assesses extent of it's resection with sonography
Primary outcome measures
- Ultrasound features of various brain mass lesions in Mair scale (in grades) [Time frame: Intraoperatively]
Secondary outcome measures (12)
- Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents) [Time frame: Intraoperatively]
- 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]
- 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]
- 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]
- 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]
- 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]
- Duration of mass lesion removal (in minutes) [Time frame: Intraoperatively]
- Extent of resection (in percents) [Time frame: Within 48 hours after surgery]
- Differentiation between artefacts and residual lesion (Yes or No) [Time frame: Intraoperatively]
- Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes) [Time frame: Intraoperatively]
- Karnofsky performance status (in percents) [Time frame: Within 10 days after surgery]
- Cerebral complications [Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Sklifosovsky Institute of Emergency Care — Moscow
Identifiers
NCT: NCT05484245 · 9g