NCT05484245

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2022Aug 2027

First Submitted

Initial submission to the registry

July 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

July 29, 2022

Last Update Submit

May 13, 2025

Conditions

Tumor, BrainArteriovenous MalformationsCavernomaIntracerebral Hematoma

Keywords

intraoperative sonographyintraoperative ultrasoundbrain tumorcavernomaarteriovenous malformationintracerebral hematoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents)

    Intraoperatively

  • 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

  • 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

  • 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

  • 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

  • +7 more secondary outcomes

Study Arms (1)

Surgery

EXPERIMENTAL

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

Device: Sonography

Interventions

SonographyDEVICE

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

Surgery

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all intracranial tumors
  • cavernomas
  • arteriovenous malformations
  • spontaneous (non-traumatic) intracerebral hemorrhages
  • traumatic intracerebral hemorrhages
  • supratentorial localization
  • newly diagnosed
  • age 18-100 years
  • stable hemodynamics

You may not qualify if:

  • rapid cerebral dislocation
  • previously performed brain radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sklifosovsky Institute of Emergency Care

Moscow, 129090, Russia

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsArteriovenous MalformationsHemangioma, CapillaryCerebral Hemorrhage

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeIntracranial HemorrhagesCerebrovascular DisordersHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Alexander Dmitriev, MD

    Sklifosovsky Institute of Emergency Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Dmitriev, MD

CONTACT

+7 (916) 423-54-08dmitriev@neurosklif.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 2, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)