Tumor, BrainSOMALINCT05484245
Sonography-guided Resection of Brain Mass Lesions
A study testing Sonography in people with Tumor, Brain and Meningioma of Brain, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tumor, Brain, Meningioma of Brain, Glioma
- What is being tested?
- Sonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meningioma
- glioma
- cerebral metastasis of solid tumors of any primary origin
- supratentorial localization
- age 18-80 years
- intraoperative use of sonography.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Sklifosovsky Institute of Emergency Care
Moscow, 129090
Alexander Dmitriev, MD, +7 (916) 423-54-08
About this study
Official title: Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial
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.
Read the 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).
- Conditions
- Tumor, Brain, Meningioma of Brain, Glioma, Metastasis Brain
- Being tested
- Sonography
- Keywords
- intraoperative sonography, intraoperative ultrasound, brain tumor, meningioma, glioma, cerebral metastasis
- Medical subject headings
- Brain Neoplasms, Meningioma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonographyDevice
Surgeon detects brain mass lesion and assesses extent of it's resection with sonography
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Ultrasound-guided resection of brain tumors, vascular malformations and hematomas Receives: Device: Sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate between intraoperative sonographic tumor features and preoperative neuroimaging
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
Measured: Intraoperatively
Sonographic differentiation accuracy of residual tumor and resection cavity artifacts
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.
Measured: Intraoperatively
Secondary outcomes (10)
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
Measured: Intraoperatively
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
Measured: 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)
Specificity = true absence of residual mass lesion / (true absence of residual mass lesion + false detection of residual mass lesion) x 100
Measured: 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)
Positive predictive value = true detection of residual mass lesion / (true detection of residual mass lesion + false detection of residual mass lesion) x 100
Measured: 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)
Negative predictive value = true absence of residual mass lesion / (true absence of residual mass lesion + inability to detect residual mass lesion) x 100
Measured: 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)
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
Measured: Within 48 hours after surgery
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
Measured: Intraoperatively
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Measured: Within 48 hours after surgery
Karnofsky performance status (in percents)
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Measured: Within 10 days after surgery
Cerebral complications
Which cerebral complications arose after surgery
Measured: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sklifosovsky Institute of Emergency Care
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alexander Dmitriev, Sklifosovsky Institute of Emergency Care
- Investigators
- Alexander Dmitriev, MD, Principal investigator, Sklifosovsky Institute of Emergency Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484245
- Sponsor's protocol ID
- 9g
- Acronym
- SOMALI
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05484245
- Acronym / sponsor ID
- SOMALI / 9g
- Conditions
- Tumor, Brain, Meningioma of Brain, Glioma, Metastasis Brain
- Keywords
- intraoperative sonography, intraoperative ultrasound, brain tumor, meningioma, glioma, cerebral metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sklifosovsky Institute of Emergency CareOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Device: SonographyUltrasound-guided resection of brain tumors, vascular malformations and hematomas |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- meningioma
- glioma
- cerebral metastasis of solid tumors of any primary origin
- supratentorial localization
- age 18-80 years
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonographySurgeon detects brain mass lesion and assesses extent of it's resection with sonography | Device | Surgery |
Primary outcome
Concordance rate between intraoperative sonographic tumor features and preoperative neuroimaging
Time frame: 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
Time frame: 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.
10 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Dmitriev, MD principal investigator
Sklifosovsky Institute of Emergency Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonography in people with Tumor, Brain and Meningioma of Brain, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Dmitriev, MD (+7 (916) 423-54-08, dmitriev@neurosklif.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate between intraoperative sonographic tumor features and preoperative neuroimaging (time frame: Intraoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.