Use of Shear Wave Elastography for Intraoperative Brain and Tumor Stiffness Measurements

March 23, 2026 updated by: Mayo Clinic
This study investigates the role of intraoperative shear wave elastography ultrasound (ISWEU) in identifying healthy brain and tumor tissue stiffness differences. This data may be used to guide tumor resection in future patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Determine the feasibility of utilizing ISWEU measurements intraoperatively and in the human brain to measure tissue stiffness.

OUTLINE: This is an observational study.

Patients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Alfredo Quinones-Hinojosa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults >= 18 years with a brain tumor diagnosis that will undergo brain surgery with tissue resection as standard of care.

Description

Inclusion Criteria:

  • Patients must be at least 18 years old.
  • Patients must have planned surgery for resection of a newly diagnosed or recurrent brain tumors.
  • Patients with tumors located in the brain cortex or superficial white matter in which introduction of the ultrasound probe is straightforward and does not pose a risk for intraoperative complications.
  • Patients must have a Karnofsky performance status ≥ 60%.
  • Patient or legally authorized representative (LAR) willing to provide written informed consent.

Exclusion Criteria:

  • Patients with deep-seated brain tumors in which introduction of the ultrasound probe poses an increased risk.
  • Patients with a history of any brain infections.
  • Patients with implanted devices.
  • Patients with any other neurological/neurosurgical disease that could affect tissue stiffness.
  • Patients with any other structural brain defect that could affect tissue stiffness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness.
Time Frame: At baseline
After intraoperative measurement of brain stiffness using ISWEU, analysis will be conducted after each procedure by determining the tissue stiffness from different areas (tumor core, peritumoral brain zone, and non-cancerous brain tissue) and comparing the tumor stiffness between patients. Reviewers will determine whether ISWEU is feasible to be used as a tool to influence surgical decision.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Alfredo Quinones-Hinojosa, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 28, 2033

Study Completion (Estimated)

June 28, 2033

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-003917 (Other Identifier: Mayo Clinic in Florida)
  • NCI-2024-07560 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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