Recruiting

Neuronavigation

Sponsor:

Washington University School of Medicine

Code:

NCT05864976

Conditions

Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Support Vector Machine

Study Details

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.

Conditions

Glioblastoma Multiforme

Study ID

NCT05864976

Start date

Dec 6, 2023

Status verified date

Jun, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Standard of care rsfMRI using the Support Vector Machine algorithm

  • 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.

Interventions

Support Vector Machine

Machine learning algorithm

Primary outcome measure

  • Number of participants who are deemed as short-term survivor or a long-term survivor [ Time Frame: Through completion of follow-up (estimated to be 2 years) ]

Central Contacts and Locations

Central contacts

Dimitrios Mathios, M.D.

314-747-6146mathios@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Dimitrios Mathios, M.D.

314-747-6146mathios@wustl.edu

Principal Investigator:

Dimitrios Mathios, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-06-30.