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

Completed

• Conditions: Anesthesia
• Interventions: Device: shear wave elastography

• Registration Number: NCT01903343
• Lead Sponsor: University of Dundee

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Study Start: 2014-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	shear wave elastography	Single group of healthy male medical students at Ninewells Hospital \& Medical School, Dundee.

Primary Outcome Measures

Name	Time	Method
To determine the reproducibility of Young's modulus in volunteers using shear wave elastography	4 hours	To determine the reproducibility of Young's modulus in volunteers using shear wave elastography
To determine the repeatability Young's modulus in volunteers using shear wave elastography	4 hours	To determine the repeatability Young's modulus in volunteers using shear wave elastography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anaesthesia, Ninewells Hospital & Medical School; 🇬🇧 Dundee, United Kingdom