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RecruitingNCT05484245SOMALIUpdated Oct 15, 2026

Sonography-guided Resection of Brain Mass Lesions

An interventional study of Sonography in Tumor, Brain, Meningioma of Brain and Glioma, sponsored by Sklifosovsky Institute of Emergency Care. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Sklifosovsky Institute of Emergency Care · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 2 months later.
Updated Oct 15, 2026Eligibility revisedPrimary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Tumor, Brain
  • Meningioma of Brain
  • Glioma
  • Metastasis Brain

Keywords

  • intraoperative sonography
  • intraoperative ultrasound
  • brain tumor
  • meningioma
  • glioma
  • cerebral metastasis
03

In context

Brain Neoplasms

2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Sklifosovsky Institute of Emergency Care is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 15, 2026. See what changed

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • meningioma
  • glioma
  • cerebral of solid tumors of any primary origin
  • supratentorial localization
  • age 18-80 years
  • intraoperative use of sonography.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Surgery

    Ultrasound-guided resection of brain tumors, vascular malformations and hematomas

    Device: Sonography

Interventions

  • DeviceSonography

    Surgeon detects brain mass lesion and assesses extent of it's resection with sonography

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Intraoperatively

  2. 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.

    Time frame: Intraoperatively

Secondary outcomes

  1. 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

    Time frame: Intraoperatively

  2. 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

    Time frame: Within 48 hours after surgery

  3. 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

    Time frame: Within 48 hours after surgery

  4. 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

    Time frame: Within 48 hours after surgery

  5. 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

    Time frame: Within 48 hours after surgery

  6. 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

    Time frame: Within 48 hours after surgery

  7. 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

    Time frame: Intraoperatively

  8. Extent of resection (in percents)

    Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

    Time frame: Within 48 hours after surgery

  9. Karnofsky performance status (in percents)

    Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale

    Time frame: Within 10 days after surgery

  10. Cerebral complications

    Which cerebral complications arose after surgery

    Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days

07

Study locations

1 of 1 sites recruiting
  • Sklifosovsky Institute of Emergency Care
    Moscow, 129090, Russia
    Recruiting
    • Alexander Dmitriev, MD · Contact+7 (916) 423-54-08
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2022 (actual). Primary completion is estimated for Aug 2027, 59 months after the start.

Of 306 non-industry interventional studies with no phase under Brain Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 125. This study's planned 59 months is close to that.

Counting every sponsor, half of 317 studies reached it within 64 months; a quarter within 35 and three quarters within 125.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2022
First posted
Aug 2, 2022
StartActual
Sep 1, 2022
Primary completionEst.
Aug 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
Maximum age 100 Years→80 Years; Criteria largely rewritten (16 changes)
What changed in the criteria
Inclusion criteria
  • Removedall intracranial tumors
  • Removedcavernomas
  • Removedarteriovenous malformations
  • Removedspontaneous (non-traumatic) intracerebral hemorrhages
  • Removedtraumatic intracerebral hemorrhages
  • Addedmeningioma
  • Addedglioma
  • Addedcerebral metastasis of solid tumors of any primary origin
  • Removednewly diagnosed
  • Editedage 18-10080 years
  • Removedstable hemodynamics
  • Addedintraoperative use of sonography.
Exclusion criteria
  • Removedrapid cerebral dislocation
  • Removedpreviously performed brain radiotherapy
  • Addedhistory of brain tumor radiotherapy (except for a single-session stereotactic radiosurgery performed no earlier than 7 days prior to surgery)
  • Addedanatomical features of the surgical approach that preclude correct positioning of the ultrasound transducer within the operative wound.
Oct 15, 2026
Primary outcomes
2 added, 1 removed
What changed in the outcomes
  • AddedConcordance rate between intraoperative sonographic tumor features and preoperative neuroimagingTime frame: Intraoperatively
  • AddedSonographic differentiation accuracy of residual tumor and resection cavity artifactsTime frame: Intraoperatively
  • RemovedUltrasound features of various brain mass lesions in Mair scale (in grades)Time frame: Intraoperatively
Oct 15, 2026
Secondary outcomes
2 removed
What changed in the outcomes
  • RemovedDifferentiation between artefacts and residual lesion (Yes or No)Time frame: Intraoperatively
  • RemovedDuration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes)Time frame: Intraoperatively
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Eligibility Maximum age 100 Years→80 Years; Criteria largely rewritten (16 changes)
    What changed in the criteria
    Inclusion criteria
    • Removedall intracranial tumors
    • Removedcavernomas
    • Removedarteriovenous malformations
    • Removedspontaneous (non-traumatic) intracerebral hemorrhages
    • Removedtraumatic intracerebral hemorrhages
    • Addedmeningioma
    • Addedglioma
    • Addedcerebral metastasis of solid tumors of any primary origin
    • Removednewly diagnosed
    • Editedage 18-10080 years
    • Removedstable hemodynamics
    • Addedintraoperative use of sonography.
    Exclusion criteria
    • Removedrapid cerebral dislocation
    • Removedpreviously performed brain radiotherapy
    • Addedhistory of brain tumor radiotherapy (except for a single-session stereotactic radiosurgery performed no earlier than 7 days prior to surgery)
    • Addedanatomical features of the surgical approach that preclude correct positioning of the ultrasound transducer within the operative wound.
    Primary outcomes 2 added, 1 removed
    What changed in the outcomes
    • AddedConcordance rate between intraoperative sonographic tumor features and preoperative neuroimagingTime frame: Intraoperatively
    • AddedSonographic differentiation accuracy of residual tumor and resection cavity artifactsTime frame: Intraoperatively
    • RemovedUltrasound features of various brain mass lesions in Mair scale (in grades)Time frame: Intraoperatively
    Secondary outcomes 2 removed
    What changed in the outcomes
    • RemovedDifferentiation between artefacts and residual lesion (Yes or No)Time frame: Intraoperatively
    • RemovedDuration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes)Time frame: Intraoperatively
    + 6 other changes: index terms, verification date, oversight details, description, conditions and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05484245
Lead sponsor
Sklifosovsky Institute of Emergency Care
Responsible party
Alexander Dmitriev (Principal Investigator, Sklifosovsky Institute of Emergency Care) — Principal investigator
First posted
Aug 2, 2022
Start date
Sep 1, 2022
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Alexander Dmitriev, MD
Contact
dmitriev@neurosklif.ru
+7 (916) 423-54-08
Alexander Dmitriev, MD
principal investigator · Sklifosovsky Institute of Emergency Care

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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