Tumor, Brain, Meningioma of Brain, Glioma, Metastasis Brain
Conditions
Keywords
intraoperative sonography, intraoperative ultrasound, brain tumor, meningioma, glioma, cerebral metastasis
Brief summary
The study aims to perform a comparative analysis of preoperative CT/MRI and intraoperative ultrasound findings in patients with hemispheric brain tumors (meningiomas, gliomas, metastases), and to develop an intraoperative ultrasound scanning algorithm for the differential diagnosis of residual tumor tissue and sonographic artifacts within the resection cavity.
Detailed description
Intraoperative sonography is widely utilized in neuro-oncology to localize brain tumors and evaluate the extent of resection. Ultrasound remains the only imaging modality that allows for real-time visualization of brain tissue. Furthermore, it is cost-effective and integrates seamlessly into the surgical workflow without cause for disruption. The primary limitations of sonography include a steep learning curve and lower spatial resolution compared to magnetic resonance imaging (MRI). While the integration of novel acoustic coupling fluids, contrast-enhanced ultrasound and elastography has expanded its efficacy, the localization of isoechoic lesions with poorly defined margins and the elimination of resection cavity artifacts remain significant challenges. The study aims to perform a comparative analysis of preoperative MRI/CT and intraoperative ultrasound findings in patients with hemispheric brain tumors (meningiomas, gliomas, metastases), and to develop an intraoperative ultrasound scanning algorithm for the differential diagnosis of residual tumor tissue and sonographic artifacts within the resection cavity. Intraoperatively the investigator will localize tumor, correlate its sonographic characteristics with preoperative MRI/CT data, and assess the extent of resection using intraoperative ultrasound across three distinct transducer positioning modes (superficial and deep transcavity, transcortical, and via transencephalotomy approaches).
Interventions
DEVICESonography
Surgeon detects brain mass lesion and assesses extent of it's resection with sonography
Sponsors
Sklifosovsky Institute of Emergency Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* meningioma * glioma * cerebral metastasis of solid tumors of any primary origin * supratentorial localization * age 18-80 years * intraoperative use of sonography.
Exclusion criteria
* history of brain tumor radiotherapy (except for a single-session stereotactic radiosurgery performed no earlier than 7 days prior to surgery) * anatomical features of the surgical approach that preclude correct positioning of the ultrasound transducer within the operative wound.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance rate between intraoperative sonographic tumor features and preoperative neuroimaging | Intraoperatively | Assessment of target lesion visibility, size, echogenicity, homogeneity, and border demarcation in intraoperative sonography, and their direct comparison to preoperative magnetic resonance imaging or computed tomography baseline data |
| Sonographic differentiation accuracy of residual tumor and resection cavity artifacts | Intraoperatively | Evaluation of intraoperative ultrasound accuracy in assessing the extent of resection by identifying the peripheral hyperechoic ring and differentiating true residual tumor tissue from sonographic artifacts within the resection cavity across three probe positioning modes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents) | Intraoperatively | Sensitivity = true detection of mass lesion / (true detection of mass lesion + inability to detect mass lesion) x 100 |
| 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 | Sensitivity = true detection of residual mass lesion / (true detection of residual mass lesion + inability to detect residual mass lesion) x 100 |
| 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 | Specificity = true absence of residual mass lesion / (true absence of residual mass lesion + false detection of residual mass lesion) x 100 |
| 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 | Positive predictive value = true detection of residual mass lesion / (true detection of residual mass lesion + false detection of residual mass lesion) x 100 |
| 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 | Negative predictive value = true absence of residual mass lesion / (true absence of residual mass lesion + inability to detect residual mass lesion) x 100 |
| 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 | 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 |
| Duration of mass lesion removal (in minutes) | Intraoperatively | How long did in take to remove mass lesion from starting of it's dissection till final evacuation |
| Extent of resection (in percents) | Within 48 hours after surgery | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 |
| Karnofsky performance status (in percents) | Within 10 days after surgery | Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale |
| Cerebral complications | From admission to intensive care unit after surgery till hospital discharge, up to 365 days | Which cerebral complications arose after surgery |
Countries
Russia
Contacts
CONTACTAlexander Dmitriev, MD
PRINCIPAL_INVESTIGATORAlexander Dmitriev, MD
Sklifosovsky Institute of Emergency Care
Outcome results
None listed