Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning

Glioblastoma Multiforme Clinical Trial

Official title:

Advancing Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning - a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864976
• Other study ID #: 202305045
• Secondary ID: 2R01CA203861
• Status: Recruiting
• Start date: December 6, 2023
• Est. completion date: January 31, 2030

Study information

• Verified date: June 2024
• Source: Washington University School of Medicine
• Contact: Dimitrios Mathios, M.D.
• Phone: 314-747-6146
• Email: mathios[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2030
• Est. primary completion date: January 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Device:
• Support Vector Machine
Machine learning algorithm

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who are deemed as short-term survivor or a long-term survivor	-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.	Through completion of follow-up (estimated to be 2 years)

External Links

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