Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning
Recruiting
- Conditions
- Glioblastoma Multiforme
- Interventions
- Device: Support Vector Machine
- Registration Number
- NCT05864976
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
This study is investigating the use of a computer algorithm to analyze scans of the brain before surgery to predict how a person's tumor will respond to treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Must have a radiological diagnosis of a lesion in the brain with characteristics consistent with glioblastoma multiforme.
- Must be planning to undergo a pre-operative MRI.
- Must be at least 18 years old.
- Must be able to understand and willing to sign an IRB approved written informed consent document.
Exclusion Criteria
- Contraindication to MRI.
- Inability to have clinical follow-up (e.g., patient is out of town and will do follow-up elsewhere).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard of care rsfMRI using the Support Vector Machine algorithm Support Vector Machine * Once enrolled, clinical pre-surgical MRI will be done on Siemens 3T Prisma or Skyra scanners using a standard pre-surgical tumor protocol. Resting-state functional MRI (rsfMRI) will be acquired. The Support Vector Machine (SVM) algorithm will be used on this pre-surgical MRI. * Patients will undergo post-operative MRI at approximately 8-12 weeks following surgical resection to evaluate extent of resection. Patients will then undergo subsequent MRI imaging every 2-3 months as part of routine clinical care to monitor for recurrence. The following MR sequences will be acquired: pre-and post-contrast T1-weighted, T2-weighted FLAIR, diffusion weighted imaging. MRI scans will be reviewed by a board-certified neuroradiologist to determine date of radiographic progression/recurrence. Imaging features at recurrence including location, multifocality, and presence of diffuse or distant recurrence will also be recorded.
- Primary Outcome Measures
Name Time Method Number of participants who are deemed as short-term survivor or a long-term survivor Through completion of follow-up (estimated to be 2 years) -Patients will be deemed as a short-term survivor or a long-term survivor and this will be defined as overall survival as less than or greater than 14.5 months, respectively.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States