ClinicalTrials.gg
RecruitingNCT05477680BRASHUpdated Oct 15, 2026

Intraoperative Brain Shift Calculation Study

An interventional study of Navigation-guided surgery in Tumor, Brain, Meningioma of Brain and Glioma, sponsored by Sklifosovsky Institute of Emergency Care. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Sklifosovsky Institute of Emergency Care · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 2 months later.
Updated Oct 15, 2026Eligibility revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

Brain shift is the main natural cause of major navigation imprecision. Despite numerous attempts no clinical trials have demonstrated a possibility to calculate and predict its 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 lower spatial resolution, limited field of view and steep learning curve.

The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of its prediction.

For each patient the investigator intraoperatively will assess location of brain surface, and lesion margins during surgery. Postoperatively these data will be compared to tumor characteristics, patient's state and intraoperative features.

02

Conditions studied

  • Tumor, Brain
  • Meningioma of Brain
  • Glioma
  • Metastasis Brain

Keywords

  • brain shift
  • tumor
  • meningioma
  • glioma
  • cerebral metastasis
03

In context

Brain Neoplasms

2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Sklifosovsky Institute of Emergency Care is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 15, 2026. See what changed

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • meningioma
  • glioma
  • cerebral of solid tumors of any primary origin
  • supratentorial localization
  • age 18-80 years
  • intraoperative use of optical neuronavigation
  • high precision of patient's registration in the navigation system (registration error of 2 mm or less)

Exclusion criteria

Exclusion Criteria:

  • technical inability to perform accurate pre-operative registration of the patient's anatomical landmarks in the neuronavigational system
  • intraoperative displacement of the reference frame relative to the patient's head during the surgical procedure.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Surgery

    Removing different brain lesions using neuronavigation

    Device: Navigation-guided surgery

Interventions

  • DeviceNavigation-guided surgery

    Surgeon removes brain lesions and assesses brain shift with neuronavigation

06

What researchers measure

Primary outcomes

  1. Brain shift (in millimeters)

    Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location

    Time frame: Intraoperatively

Secondary outcomes

  1. Extent of resection (in percents)

    Extent of Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100resection (in percents)

    Time frame: Within 48 hours after surgery

  2. Karnofsky Performance status in percents

    Assesses patients' possibilities to self-service

    Time frame: within 10 days after surgery

  3. Cerebral complications

    Which cerebral complications arose after surgery

    Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
Maximum age 100 Years→80 Years; Criteria largely rewritten (17 changes)
What changed in the criteria
Inclusion criteria
  • Removedall intracranial tumors
  • Removedcavernomas
  • Removedarteriovenous malformations
  • Removedspontaneous (non-traumatic) intracerebral hemorrhages
  • Removedtraumatic intracerebral hemorrhages
  • Addedmeningioma
  • Addedglioma
  • Addedcerebral metastasis of solid tumors of any primary origin
  • Removednewly diagnosed
  • Editedage 18-10080 years
  • Removedstable hemodynamics
  • Removederror of patient registration in neuronavigation no more than 2 mm
  • Addedintraoperative use of optical neuronavigation
  • Addedhigh precision of patient's registration in the navigation system (registration error of 2 mm or less)
Exclusion criteria
  • Removedrapid cerebral dislocation
  • Addedtechnical inability to perform accurate pre-operative registration of the patient's anatomical landmarks in the neuronavigational system
  • Addedintraoperative displacement of the reference frame relative to the patient's head during the surgical procedure.
Oct 15, 2026
Secondary outcomes
1 added
What changed in the outcomes
  • AddedExtent of resection (in percents)Time frame: Within 48 hours after surgery
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Eligibility Maximum age 100 Years→80 Years; Criteria largely rewritten (17 changes)
    What changed in the criteria
    Inclusion criteria
    • Removedall intracranial tumors
    • Removedcavernomas
    • Removedarteriovenous malformations
    • Removedspontaneous (non-traumatic) intracerebral hemorrhages
    • Removedtraumatic intracerebral hemorrhages
    • Addedmeningioma
    • Addedglioma
    • Addedcerebral metastasis of solid tumors of any primary origin
    • Removednewly diagnosed
    • Editedage 18-10080 years
    • Removedstable hemodynamics
    • Removederror of patient registration in neuronavigation no more than 2 mm
    • Addedintraoperative use of optical neuronavigation
    • Addedhigh precision of patient's registration in the navigation system (registration error of 2 mm or less)
    Exclusion criteria
    • Removedrapid cerebral dislocation
    • Addedtechnical inability to perform accurate pre-operative registration of the patient's anatomical landmarks in the neuronavigational system
    • Addedintraoperative displacement of the reference frame relative to the patient's head during the surgical procedure.
    Secondary outcomes 1 added
    What changed in the outcomes
    • AddedExtent of resection (in percents)Time frame: Within 48 hours after surgery
    + 6 other changes: verification date, oversight details, description, conditions, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05477680
Lead sponsor
Sklifosovsky Institute of Emergency Care
Responsible party
Alexander Dmitriev (Principal Investigator, Sklifosovsky Institute of Emergency Care) — Principal investigator
First posted
Jul 28, 2022
Start date
Sep 1, 2022
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Alexander Dmitriev, MD
Contact
dmitriev@neurosklif.ru
+7 (916) 423-54-08
Alexander Dmitriev, MD
principal investigator · Sklifosovsky Institute of Emergency Care

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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