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Completed

NCT Number: NCT01903343

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Anaesthesia, Ninewells Hospital & Medical School

Dundee, DD19SY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shear Wave Elastography

Device

ultrasound

Primary outcomes

  1. To determine the reproducibility of Young's modulus in volunteers using shear wave elastography

    Time frame: 4 hours

    To determine the reproducibility of Young's modulus in volunteers using shear wave elastography

  2. To determine the repeatability Young's modulus in volunteers using shear wave elastography

    Time frame: 4 hours

    To determine the repeatability Young's modulus in volunteers using shear wave elastography

Secondary outcomes

  1. Video Young's Modulus

    Time frame: max 2 minutes

    To video changes in tissue stiffness (using the elastography colour map) in concert with changes in the B-Mode image

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 19, 2013
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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