We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Brain Shift Calculation Study (BRASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05477680
Recruitment Status : Recruiting
First Posted : July 28, 2022
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Alexander Dmitriev, Sklifosovsky Institute of Emergency Care

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

Condition or disease Intervention/treatment Phase
Tumor, Brain Cavernoma Arteriovenous Malformations Intracerebral Hematoma Device: Navigation-guided surgery Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : August 31, 2027
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgery
Removing different brain lesions using neuronavigation
Device: Navigation-guided surgery
Surgeon removes brain lesions and assesses brain shift with neuronavigation




Primary Outcome Measures :
  1. Brain shift (in millimeters) [ Time Frame: Intraoperatively ]
    Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • error of patient registration in neuronavigation no more than 2 mm

Exclusion Criteria:

  • rapid cerebral dislocation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05477680


Contacts
Layout table for location contacts
Contact: Alexander Dmitriev, MD +7 (916) 423-54-08 dmitriev@neurosklif.ru

Locations
Layout table for location information
Russian Federation
Sklifosovsky Institute of Emergency Care Recruiting
Moscow, Russian Federation, 129090
Contact: Alexander Dmitriev, MD    +7 (916) 423-54-08    dmitriev@neurosklif.ru   
Sponsors and Collaborators
Sklifosovsky Institute of Emergency Care
Investigators
Layout table for investigator information
Principal Investigator: Alexander Dmitriev, MD Sklifosovsky Institute of Emergency Care
Layout table for additonal information
Responsible Party: Alexander Dmitriev, Principal Investigator, Sklifosovsky Institute of Emergency Care
ClinicalTrials.gov Identifier: NCT05477680    
Other Study ID Numbers: 9e
First Posted: July 28, 2022    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Dmitriev, Sklifosovsky Institute of Emergency Care:
brain shift
tumor
cavernoma
arteriovenous malformation
intracerebral hematoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Hemangioma, Cavernous
Cerebral Hemorrhage
Arteriovenous Malformations
Congenital Abnormalities
Hematoma
Hemorrhage
Pathologic Processes
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders