Sonography-guided Resection of Brain Mass Lesions

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05484245
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sklifosovsky Institute of Emergency Care
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexander Dmitriev, MD
Principal Investigator Affiliation	Sklifosovsky Institute of Emergency Care
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Tumor, Brain, Arteriovenous Malformations, Cavernoma, Intracerebral Hematoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Surgery

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

Interventions

Device: - Sonography

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

Contact a Trial Team

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International Sites

Sklifosovsky Institute of Emergency Care, Moscow, Russian Federation

Status

Recruiting

Address

Sklifosovsky Institute of Emergency Care

Moscow, , 129090

Site Contact

Alexander Dmitriev, MD

[email protected]

+7 (916) 423-54-08

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