Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05864976
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme	Device: Support Vector Machine

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Advancing Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning - a Prospective Study
• Anticipated Study Start Date: Jun 30, 2023
• Anticipated Primary Completion Date: Jun 30, 2029
• Anticipated Study Completion Date: Jun 30, 2029

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Support Vector Machine; Machine learning algorithm

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be a new radiological diagnose of a lesion in the brain with characteristics consistent with glioblastoma multiforme. Diagnostic scan must have occurred no more than 1 month prior to enrollment.

• Must be planning to undergo a clinical 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.

• Previous surgery for a brain tumor.

• Inability to have clinical follow-up (e.g., patient is out of town and will do follow-up elsewhere).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Eric Leuthardt, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT05864976
• Other Study ID Numbers: 23-x086; 2R01CA203861
• First Posted: May 18, 2023
• Last Update Posted: May 18, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Glioblastoma

Study Results

No Results Posted as of May 18, 2023