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Not yet recruiting NCT06630338

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

— Observational Brain Tumor Recurrent Brain Tumor Brain Neoplasm Recurrent Brain Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Brain Tumor, Recurrent Brain Tumor, Brain Neoplasm, Recurrent Brain Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness. [Time frame: At baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT06630338 · 24-003917 · NCI-2024-07560 · 24-003917

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗