Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05864976
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Washington University School of Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dimitrios Mathios, M.D.
Principal Investigator Affiliation	Washington University School of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme
Study Website:	View Trial Website

Arms & Interventions

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

Device: - Support Vector Machine

Machine learning algorithm

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Dimitrios Mathios, M.D.

[email protected]

314-747-6146

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