SuspendedNot Applicable

Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations

Stopped: technical issues

Russia50 participantsStarted 2022-09-01

Plain-language 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.

Who can participate

Age range18 Years – 79 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * all intracranial tumors * arteriovenous malformations * cavernous malformations * supratentorial localization * newly diagnosed * age 18-79 years * unaltered consciousness * error of patient registration in neuronavigation no more than 2 mm * possibility to perform "positive mapping" strategy Exclusion Criteria: * 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

What they're measuring

Accuracy of functional navigation (in millimeters)

Timeframe: Intraoperatively

Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)

Timeframe: Intraoperatively

Trial details

NCT IDNCT05484219

SponsorSklifosovsky Institute of Emergency Care

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-08-31

View on ClinicalTrials.gov More Tumor, Brain trials