Tumor, BrainBRASHNCT05477680
Intraoperative Brain Shift Calculation Study
A study testing Navigation-guided surgery in people with Tumor, Brain and Meningioma of Brain, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
Trial summary
The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tumor, Brain, Meningioma of Brain, Glioma
- What is being tested?
- Navigation-guided surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meningioma
- glioma
- cerebral metastasis 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Sklifosovsky Institute of Emergency Care
Moscow, 129090
Alexander Dmitriev, MD, +7 (916) 423-54-08, dmitriev@neurosklif.ru
About this study
Official title: Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
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.
- Conditions
- Tumor, Brain, Meningioma of Brain, Glioma, Metastasis Brain
- Being tested
- Navigation-guided surgery
- Keywords
- brain shift, tumor, meningioma, glioma, cerebral metastasis
- Medical subject headings
- Brain Neoplasms, Meningioma, Glioma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation-guided surgeryDevice
Surgeon removes brain lesions and assesses brain shift with neuronavigation
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Removing different brain lesions using neuronavigation Receives: Device: Navigation-guided surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain shift (in millimeters)
Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location
Measured: Intraoperatively
Secondary outcomes (3)
Extent of resection (in percents)
Extent of Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100resection (in percents)
Measured: Within 48 hours after surgery
Karnofsky Performance status in percents
Assesses patients' possibilities to self-service
Measured: within 10 days after surgery
Cerebral complications
Which cerebral complications arose after surgery
Measured: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sklifosovsky Institute of Emergency Care
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alexander Dmitriev, Sklifosovsky Institute of Emergency Care
- Investigators
- Alexander Dmitriev, MD, Principal investigator, Sklifosovsky Institute of Emergency Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477680
- Sponsor's protocol ID
- 9e
- Acronym
- BRASH
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05477680
- Acronym / sponsor ID
- BRASH / 9e
- Conditions
- Tumor, Brain, Meningioma of Brain, Glioma, Metastasis Brain
- Keywords
- brain shift, tumor, meningioma, glioma, cerebral metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sklifosovsky Institute of Emergency CareOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Device: Navigation-guided surgeryRemoving different brain lesions using neuronavigation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- meningioma
- glioma
- cerebral metastasis of solid tumors of any primary origin
- supratentorial localization
- age 18-80 years
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigation-guided surgerySurgeon removes brain lesions and assesses brain shift with neuronavigation | Device | Surgery |
Primary outcome
Brain shift (in millimeters)
Time frame: Intraoperatively
Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location
3 secondary outcomes
Extent of resection (in percents)
Time frame: Within 48 hours after surgery
Karnofsky Performance status in percents
Time frame: within 10 days after surgery
Cerebral complications
Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Dmitriev, MD principal investigator
Sklifosovsky Institute of Emergency Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation-guided surgery in people with Tumor, Brain and Meningioma of Brain, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Dmitriev, MD (+7 (916) 423-54-08, dmitriev@neurosklif.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain shift (in millimeters) (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.