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Trial Title:
Sonography-guided Resection of Brain Mass Lesions
NCT ID:
NCT05484245
Condition:
Tumor, Brain
Arteriovenous Malformations
Cavernoma
Intracerebral Hematoma
Conditions: Official terms:
Brain Neoplasms
Hemangioma, Cavernous
Cerebral Hemorrhage
Arteriovenous Malformations
Congenital Abnormalities
Hematoma
Conditions: Keywords:
intraoperative sonography
intraoperative ultrasound
brain tumor
cavernoma
arteriovenous malformation
intracerebral hematoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Sonography
Description:
Surgeon detects brain mass lesion and assesses extent of it's resection with sonography
Arm group label:
Surgery
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sklifosovsky Institute of Emergency Care
Address:
City:
Moscow
Zip:
129090
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Alexander Dmitriev, MD
Phone:
+7 (916) 423-54-08
Start date:
September 1, 2022
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Sklifosovsky Institute of Emergency Care
Agency class:
Other
Source:
Sklifosovsky Institute of Emergency Care
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05484245