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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
Sklifosovsky Institute of Emergency Care
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 25, 2022
Last Updated
November 28, 2022
Sponsor
Sklifosovsky Institute of Emergency Care
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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

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Intraoperative Brain Shift Calculation Study

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