Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers

Study Overview
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Brief Summary
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The aim of the study is to assess the accuracy of shear wave elastography in volunteers. Shear wave elastography is a non-invasive, non-painful measure of tissue stiffness obtained using an ultrasound machine. It may be easier to think of shear wave elastography as a special type of ultrasound imaging which gives doctors a colour picture of body structures based on their stiffness.

Detailed Description
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Shear wave elastography is a quantitative ultrasound modality increasingly used to differentiate between hard breast cancer masses and soft normal tissue. Unlike strain elastography, shear wave elastography applies a non-compressive longitudinal acoustic radiation force to underlying tissues, inducing transverse shear waves. Studies in Thiel embalmed human cadavers have shown significant differences in Young's modulus between intraneural and extraneural tissue, and ready colour differentiation between tissues. Therefore, before clinical application, we wish to measure the repeatability and reproducibility of Young's modulus of intraneural and extraneural tissue in volunteers. For measurement, a region of interest (ROI) will be selected over the appropriate nerve and adjacent tissue. The ROI results will be regarded as paired data. Paired data will be measured over and adjacent to the interscalene C5 nerve root, infraclavicular lateral cord, musculocutaneous, median, femoral, saphenous and sciatic nerves.

Official Title
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Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers

Conditions
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Anesthesia

Intervention / Treatment
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* Device: shear wave elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fit healthy male volunteers between 18 and 35 years of age. Participants with an ASA score of 1. Capacity to provide informed consent. Exclusion Criteria: All females. Male participants aged <18 years and >35 years of age. ASA score 2 or above.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>Single group of healthy male medical students at Ninewells Hospital & Medical School, Dundee. | Device: shear wave elastography<br>* ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the reproducibility of Young's modulus in volunteers using shear wave elastography | To determine the reproducibility of Young's modulus in volunteers using shear wave elastography | 4 hours | 
| To determine the repeatability Young's modulus in volunteers using shear wave elastography | To determine the repeatability Young's modulus in volunteers using shear wave elastography | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Video Young's Modulus | To video changes in tissue stiffness (using the elastography colour map) in concert with changes in the B-Mode image | max 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shear wave, Elastography, Repeatability and Reproducibility