Sonography-guided Resection of Brain Mass Lesions (SOMALI)
Primary Purpose
Tumor, Brain, Arteriovenous Malformations, Cavernoma
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Sonography
Sponsored by
About this trial
This is an interventional treatment trial for Tumor, Brain focused on measuring intraoperative sonography, intraoperative ultrasound, brain tumor, cavernoma, arteriovenous malformation, intracerebral hematoma
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
Sites / Locations
- Sklifosovsky Institute of Emergency CareRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery
Arm Description
Ultrasound-guided resection of brain tumors, vascular malformations and hematomas
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Differentiation between artefacts and residual lesion (Yes or No)
Possibility of ultrasound differentiation between artefacts and residual lesion
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
Karnofsky performance status (in percents)
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Cerebral complications
Which cerebral complications arose after surgery
Full Information
NCT ID
NCT05484245
First Posted
July 29, 2022
Last Updated
November 28, 2022
Sponsor
Sklifosovsky Institute of Emergency Care
1. Study Identification
Unique Protocol Identification Number
NCT05484245
Brief Title
Sonography-guided Resection of Brain Mass Lesions
Acronym
SOMALI
Official Title
Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sklifosovsky Institute of Emergency Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Brain, Arteriovenous Malformations, Cavernoma, Intracerebral Hematoma
Keywords
intraoperative sonography, intraoperative ultrasound, brain tumor, cavernoma, arteriovenous malformation, intracerebral hematoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Experimental
Arm Description
Ultrasound-guided resection of brain tumors, vascular malformations and hematomas
Intervention Type
Device
Intervention Name(s)
Sonography
Intervention Description
Surgeon detects brain mass lesion and assesses extent of it's resection with sonography
Primary Outcome Measure Information:
Title
Ultrasound features of various brain mass lesions in Mair scale (in grades)
Description
Assessment of target visibility, echogenicity, homogeneity and border demarcation in sonography and their comparison to preoperative computed tomography and magnetic resonance imaging
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents)
Description
Sensitivity = true detection of mass lesion / (true detection of mass lesion + inability to detect mass lesion) x 100
Time Frame
Intraoperatively
Title
Sensitivity of intraoperative sonography to detect residual mass lesion compared to postoperative magnetic resonance imaging or computed tomography (in percents)
Description
Sensitivity = true detection of residual mass lesion / (true detection of residual mass lesion + inability to detect residual mass lesion) x 100
Time Frame
Within 48 hours after surgery
Title
Specificity of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
Description
Specificity = true absence of residual mass lesion / (true absence of residual mass lesion + false detection of residual mass lesion) x 100
Time Frame
Within 48 hours after surgery
Title
Positive predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
Description
Positive predictive value = true detection of residual mass lesion / (true detection of residual mass lesion + false detection of residual mass lesion) x 100
Time Frame
Within 48 hours after surgery
Title
Negative predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
Description
Negative predictive value = true absence of residual mass lesion / (true absence of residual mass lesion + inability to detect residual mass lesion) x 100
Time Frame
Within 48 hours after surgery
Title
Accuracy of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)
Description
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
Time Frame
Within 48 hours after surgery
Title
Duration of mass lesion removal (in minutes)
Description
How long did in take to remove mass lesion from starting of it's dissection till final evacuation
Time Frame
Intraoperatively
Title
Extent of resection (in percents)
Description
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time Frame
Within 48 hours after surgery
Title
Differentiation between artefacts and residual lesion (Yes or No)
Description
Possibility of ultrasound differentiation between artefacts and residual lesion
Time Frame
Intraoperatively
Title
Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes)
Description
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
Time Frame
Intraoperatively
Title
Karnofsky performance status (in percents)
Description
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Time Frame
Within 10 days after surgery
Title
Cerebral complications
Description
Which cerebral complications arose after surgery
Time Frame
From admission to intensive care unit after surgery till hospital discharge, up to 365 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Organizational Affiliation
Sklifosovsky Institute of Emergency Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sklifosovsky Institute of Emergency Care
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
12. IPD Sharing Statement
Plan to Share IPD
No
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Sonography-guided Resection of Brain Mass Lesions
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