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Spots Global Cancer Trial Database for Intraoperative Brain Shift Calculation Study

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Trial Identification

Brief Title: Intraoperative Brain Shift Calculation Study

Official Title: Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial

Study ID: NCT05477680

Study Description

Brief Summary: The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

Detailed Description: Brain shift is the main natural cause of major navigation imprecision. Despite numerous attempts no trials showed a possibility to calculate and predict it's value although some patterns were found. Some modern navigational features allow to partially resolve this problem. Manual shift correction allows to displace brain structures but can only be used if brain shift is linear. Intraoperative computed tomography (CT) and magnetic resonance imaging (MRI) allow to update navigational data but violate surgical workflow and cannot display brain tissue in real time. Intraoperative sonography has poorer quality, limited observe volume and lengthy learning curve. The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction. For each patient a surgeon intraoperatively will assess location of brain surface, various intracranial structures and lesion margins during surgery. Postoperatively these data will be compared to lesion's characteristics, patient's state and intraoperative features.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sklifosovsky Institute of Emergency Care, Moscow, , Russian Federation

Contact Details

Name: Alexander Dmitriev, MD

Affiliation: Sklifosovsky Institute of Emergency Care

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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