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NCT Number: NCT06630338

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location contact

Alfredo Quinones-Hinojosa, MD

PRINCIPAL_INVESTIGATOR

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. 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.

Study contacts

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

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Oct 8, 2024
Registry last updated
Mar 27, 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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