Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID05484245

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

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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

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