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

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Mayo Clinic

Status

Begins enrollment in 3 months

Conditions

Recurrent Brain Neoplasm
Brain Tumor
Brain Neoplasm
Recurrent Brain Tumor

Treatments

Other: Non-Interventional Study

Study type

Observational

Funder types

Other

Identifiers

NCT06630338
NCI-2024-07560 (Registry Identifier)
24-003917 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Clinical Trials Referral Office

Data sourced from clinicaltrials.gov

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