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NCT Number: NCT05864976

Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning

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.

Recruiting

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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Abraham Synder, M.D., Ph.D.

SUB_INVESTIGATOR

Dimitrios Mathios, M.D.

CONTACT

[email protected]

314-747-6146

Dimitrios Mathios, M.D.

PRINCIPAL_INVESTIGATOR

Eric Leuthardt, M.D.

SUB_INVESTIGATOR

Feng Gao, Ph.D.

SUB_INVESTIGATOR

Joshua Shimony, M.D.

SUB_INVESTIGATOR

Milan Chheda, M.D.

SUB_INVESTIGATOR

Patrick Luckett, Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Support Vector Machine

Device

Machine learning algorithm

Primary outcomes

  1. 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)

    -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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitrios Mathios, M.D.

CONTACT

[email protected]

314-747-6146

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
May 18, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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