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

NCT ID: NCT06630338

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-06-01

Study Completion Date

2033-06-28

Brief Summary

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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

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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.

Conditions

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Brain Tumor Recurrent Brain Tumor Brain Neoplasm Recurrent Brain Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfredo Quinones-Hinojosa, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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NCI-2024-07560

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-003917

Identifier Type: OTHER

Identifier Source: secondary_id

24-003917

Identifier Type: -

Identifier Source: org_study_id

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