Tumor, BrainFUNNCT05484219
Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations
A study testing Functional navigation in people with Tumor, Brain and Arteriovenous Malformations, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
Trial summary
The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Tumor, Brain, Arteriovenous Malformations, Cavernoma
- What is being tested?
- Functional navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all intracranial tumors
- arteriovenous malformations
- cavernous malformations
- supratentorial localization
- newly diagnosed
- age 18-79 years
Show all 9Show fewer
- unaltered consciousness
- error of patient registration in neuronavigation no more than 2 mm
- possibility to perform "positive mapping" strategy
Who cannot join
- contraindications to magnetic resonance imaging or transcranial magnetic stimulation
- inability to build tractography in neuronavigation
- predicting of intraoperative brain shift 6 mm and more without possibility to correct it
- real intraoperative brain shift 6 mm and more without possibility to correct it
- previously performed brain radiotherapy
- pregnancy
- breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations: a Prospective, Single Arm Clinical Trial
The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery.
Read the detailed description
Functional images (functional magnetic resonance imaging (fMRI), transcranial magnetic stimulation (TMS), tractography) loaded in neuronavigation are called functional navigation. It is usually combined with anatomical data and allows to display eloquent brain areas. Currently there are plenty of studies concerning possibilities of it's use. In our research we plan to confirm this data and to supplement them with calculating a safe distance from motor areas to various mass lesions in preoperative scans where neurological deficits is not likely to appear after surgery. In case of success this data can be a foundation for further researches specifying indications for use of intraoperative neuromonitoring and possibility of it's replacement with functional navigation in some cases.
The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery. For each patient a surgeon intraoperatively will assess locations of motor cortex and corticospinal tract found with direct cortical and subcortical stimulation and capture them. After surgery he will compare this data with functional preoperative scans and virtual motor centers constructed based on tractography. Influence of various factors on precision of functional navigation will be studied and safe distance between motor brain areas and mass lesion borders will be calculated.
- Conditions
- Tumor, Brain, Arteriovenous Malformations, Cavernoma
- Being tested
- Functional navigation
- Keywords
- brain tumor, arteriovenous malformation, cavernoma, cavernous malformation, functional navigation
- Medical subject headings
- Brain Neoplasms, Arteriovenous Malformations, Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional navigationDevice
Surgeon removes brain tumor or vascular malformation and assesses location of motor areas with functional navigation and intraoperative neuromonitoring
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Image-guided resection of brain tumors and vascular malformations Receives: Device: Functional navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of functional navigation (in millimeters)
Maximal distance from the most remote margin of cortical hand/leg motor area or corticospinal tract in the area of corona radiata in functional navigation to the nearest margin of this area/tract in direct cortical/subcortical stimulation
Measured: Intraoperatively
Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)
Maximal distance from the most remote margin of cortical hand/leg motor area, built according to tractography and loaded into navigation, to the nearest margin of this area in direct cortical stimulation
Measured: Intraoperatively
Secondary outcomes (9)
Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)
Maximal distance from the most remote margin of cortical hand/leg motor area in fMRI/TMS to the nearest margin of precentral gyrus
Measured: Within 2 days before surgery
Factors, violating precision of fMRI/TMS/tractography
Which factors lead to disappearing, thinning and dislocation of cortical hand/leg motor areas and corticospinal tract in fMRI/TMS/tractography
Measured: Within 2 days before surgery
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Measured: Within 10 days after surgery
Distance to stop resection border (in millimeters)
Minimal distance from the nearest margin of cortical hand/leg motor area or corticospinal tract to the nearest border of resection of tumor/vascular malformation
Measured: Intraoperatively
Safe resection distance in functional navigation (in millimeters)
This outcome is only measured in patients with no deterioration of motor function after surgery. Safe resection distance = accuracy of functional navigation + distance to stop resection border
Measured: Within 10 days after surgery
Duration of direct cortical and subcortical mapping (in minutes)
How long did it take to perform direct cortical and subcortical mapping
Measured: Intraoperatively
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Measured: Within 48 hours after surgery
Karnofsky performance status (in percents)
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
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 posted2 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Why it stopped: technical issues
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
- 50 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
- NCT05484219
- Sponsor's protocol ID
- 9f
- Acronym
- FUN
- Status last verified
- May 2025
- First submitted
- 29 Jul 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations: a Prospective, Single Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05484219
- Acronym / sponsor ID
- FUN / 9f
- Conditions
- Tumor, Brain, Arteriovenous Malformations, Cavernoma
- Keywords
- brain tumor, arteriovenous malformation, cavernoma, cavernous malformation, functional navigation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: technical issues
- Enrolment
- 50 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
- 2 Aug 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 assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery.
Detailed description
Functional images (functional magnetic resonance imaging (fMRI), transcranial magnetic stimulation (TMS), tractography) loaded in neuronavigation are called functional navigation. It is usually combined with anatomical data and allows to display eloquent brain areas. Currently there are plenty of studies concerning possibilities of it's use. In our research we plan to confirm this data and to supplement them with calculating a safe distance from motor areas to various mass lesions in preoperative scans where neurological deficits is not likely to appear after surgery. In case of success this data can be a foundation for further researches specifying indications for use of intraoperative neuromonitoring and possibility of it's replacement with functional navigation in some cases.
The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery. For each patient a surgeon intraoperatively will assess locations of motor cortex and corticospinal tract found with direct cortical and subcortical stimulation and capture them. After surgery he will compare this data with functional preoperative scans and virtual motor centers constructed based on tractography. Influence of various factors on precision of functional navigation will be studied and safe distance between motor brain areas and mass lesion borders will be calculated.
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: Functional navigationImage-guided resection of brain tumors and vascular malformations |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- all intracranial tumors
- arteriovenous malformations
- cavernous malformations
- supratentorial localization
- newly diagnosed
Key exclusion criteria (7 listed)
- contraindications to magnetic resonance imaging or transcranial magnetic stimulation
- inability to build tractography in neuronavigation
- predicting of intraoperative brain shift 6 mm and more without possibility to correct it
- real intraoperative brain shift 6 mm and more without possibility to correct it
- previously performed brain radiotherapy
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 |
|---|---|---|
| Functional navigationSurgeon removes brain tumor or vascular malformation and assesses location of motor areas with functional navigation and intraoperative neuromonitoring | Device | Surgery |
Primary outcome
Accuracy of functional navigation (in millimeters)
Time frame: Intraoperatively
Maximal distance from the most remote margin of cortical hand/leg motor area or corticospinal tract in the area of corona radiata in functional navigation to the nearest margin of this area/tract in direct cortical/subcortical stimulation
Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)
Time frame: Intraoperatively
Maximal distance from the most remote margin of cortical hand/leg motor area, built according to tractography and loaded into navigation, to the nearest margin of this area in direct cortical stimulation
9 secondary outcomes
Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)
Time frame: Within 2 days before surgery
Factors, violating precision of fMRI/TMS/tractography
Time frame: Within 2 days before surgery
Motor function (in grades)
Time frame: Within 10 days after surgery
Distance to stop resection border (in millimeters)
Time frame: Intraoperatively
Safe resection distance in functional navigation (in millimeters)
Time frame: Within 10 days after surgery
Duration of direct cortical and subcortical mapping (in minutes)
Time frame: Intraoperatively
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
Related trials for Tumor, Brain
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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. This study is not recruiting at the moment.
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 Functional navigation in people with Tumor, Brain and Arteriovenous Malformations, 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 9 inclusion and 7 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: paused, as of the sponsor's last update on 16 May 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of functional navigation (in millimeters) (time frame: Intraoperatively). The study lists 2 primary outcomes in all. 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 16 May 2025.