Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning

NCT ID: NCT05864976

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-06

Study Completion Date

2030-01-31

Brief Summary

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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

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Conditions

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Glioblastoma Multiforme

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Support Vector Machine

Intervention Type DEVICE

Machine learning algorithm

Interventions

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Support Vector Machine

Machine learning algorithm

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dimitrios Mathios, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dimitrios Mathios, M.D.

Role: CONTACT

314-747-6146

Facility Contacts

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Dimitrios Mathios, M.D.

Role: primary

314-747-6146

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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2R01CA203861

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202305045

Identifier Type: -

Identifier Source: org_study_id

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