Actively Recruiting
Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial
Led by Sklifosovsky Institute of Emergency Care · Updated on 2025-05-16
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the use of intraoperative sonography for detecting and assessing brain mass lesions such as tumors, vascular malformations, cavernomas, and hematomas during surgery. Sonography is used to observe brain tissue in real time, offering a cheaper and workflow-friendly option compared to traditional imaging, though it has challenges like a learning curve and lower image quality than MRI. The study seeks to define when ultrasound-guided needles or wire-guided ports are helpful for reaching deep or small lesions. During surgery, the surgeon will use ultrasound through the surgical opening to locate the brain mass and evaluate how much has been removed. Scanning may be done periodically or continuously through the same or an expanded opening. The study also involves using ultrasound-guided tools to assist in accessing deeper brain areas. This is a single-arm clinical trial assessing ultrasound-guided resection of various brain lesions. Participants will be evaluated with ultrasound during surgery and undergo imaging tests like MRI or CT before and after surgery to compare findings. Researchers will measure ultrasound features of lesions, accuracy in detecting residual masses, surgery durations, and patient recovery status. Monitoring includes cerebral complications from ICU admission until hospital discharge, lasting up to one year. The trial spans from initial surgery through post-operative assessments within days and long-term follow-up for safety.
CONDITIONS
Brief Title
Sonography-guided Resection of Brain Mass Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All intracranial tumors
- Cavernomas
- Arteriovenous malformations
- Spontaneous (non-traumatic) intracerebral hemorrhages
- Traumatic intracerebral hemorrhages
- Supratentorial localization of lesion
- Newly diagnosed lesions
- Age between 18 and 100 years
- Stable hemodynamics
You will not qualify if you...
- Rapid cerebral dislocation
- Previously performed brain radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and up to 48 hours after surgery
Participants undergo ultrasound-guided surgery to remove brain mass lesions, with intraoperative sonography used to detect and assess the extent of lesion resection.
1 surgical procedure and assessments within 48 hours after surgery
Duration - Up to 365 days after surgery
Participants are monitored for recovery, cerebral complications, and functional status up to hospital discharge and up to 365 days after surgery.
Follow-up visits during hospital stay and periodic assessments up to 1 year
Trial Site Locations
Total: 1 location
1
Sklifosovsky Institute of Emergency Care
Moscow, Russia, 129090
Actively Recruiting
Research Team
A
Alexander Dmitriev, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1