Sonography-guided Resection of Brain Mass Lesions

Arteriovenous Malformations Clinical Trial

— SOMALI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484245
• Other study ID #: 9g
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: April 2024
• Source: Sklifosovsky Institute of Emergency Care
• Contact: Alexander Dmitriev, MD
• Phone: +7 (916) 423-54-08
• Email: dmitriev[@]neurosklif.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Brain Neoplasms
• Cavernoma
• Cerebral Hemorrhage
• Congenital Abnormalities
• Hematoma
• Intracerebral Hematoma
• Tumor, Brain

Intervention

Device:
• Sonography
Surgeon detects brain mass lesion and assesses extent of it's resection with sonography

Locations

Country	Name	City	State
Russian Federation	Sklifosovsky Institute of Emergency Care	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Sklifosovsky Institute of Emergency Care

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Extent of resection (in percents)	Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100	Within 48 hours after surgery
Secondary	Differentiation between artefacts and residual lesion (Yes or No)	Possibility of ultrasound differentiation between artefacts and residual lesion	Intraoperatively
Secondary	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
Secondary	Karnofsky performance status (in percents)	Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale	Within 10 days after surgery
Secondary	Cerebral complications	Which cerebral complications arose after surgery	From admission to intensive care unit after surgery till hospital discharge, up to 365 days