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

Not yet recruiting

• Conditions: Glioma; Recurrent Glioma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06630338
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-04
• Study First Posted: 2024-10-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25
• Study Start: 2025-06-01
• Primary Completion: 2033-06-28
• Study Completion: 2033-06-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients must be at least 18 years old.
• Patients must have planned surgery for resection of a newly diagnosed or recurrent glioma.
• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness.	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 glioma stiffness between patients. Reviewers will determine whether ISWEU is feasible to be used as a tool to influence surgical decision.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States