Intraoperative Brain Shift Calculation Study (BRASH)
Primary Purpose
Tumor, Brain, Cavernoma, Arteriovenous Malformations
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Navigation-guided surgery
Sponsored by
About this trial
This is an interventional treatment trial for Tumor, Brain focused on measuring brain shift, tumor, cavernoma, arteriovenous malformation, intracerebral hematoma
Eligibility 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
Sites / Locations
- Sklifosovsky Institute of Emergency CareRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery
Arm Description
Removing different brain lesions using neuronavigation
Outcomes
Primary Outcome Measures
Brain shift (in millimeters)
Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location
Secondary Outcome Measures
Karnofsky Performance status in percents
Assesses patients' possibilities to self-service
Cerebral complications
Which cerebral complications arose after surgery
Full Information
NCT ID
NCT05477680
First Posted
July 25, 2022
Last Updated
November 28, 2022
Sponsor
Sklifosovsky Institute of Emergency Care
1. Study Identification
Unique Protocol Identification Number
NCT05477680
Brief Title
Intraoperative Brain Shift Calculation Study
Acronym
BRASH
Official Title
Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sklifosovsky Institute of Emergency Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Brain, Cavernoma, Arteriovenous Malformations, Intracerebral Hematoma
Keywords
brain shift, tumor, cavernoma, arteriovenous malformation, intracerebral hematoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Experimental
Arm Description
Removing different brain lesions using neuronavigation
Intervention Type
Device
Intervention Name(s)
Navigation-guided surgery
Intervention Description
Surgeon removes brain lesions and assesses brain shift with neuronavigation
Primary Outcome Measure Information:
Title
Brain shift (in millimeters)
Description
Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Karnofsky Performance status in percents
Description
Assesses patients' possibilities to self-service
Time Frame
within 10 days after surgery
Title
Cerebral complications
Description
Which cerebral complications arose after surgery
Time Frame
From admission to intensive care unit after surgery till hospital discharge, up to 365 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Organizational Affiliation
Sklifosovsky Institute of Emergency Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sklifosovsky Institute of Emergency Care
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraoperative Brain Shift Calculation Study
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