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

May 3, 2019 updated by: University of Dundee
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Dundee, United Kingdom, DD19SY
        • Department of Anaesthesia, Ninewells Hospital & Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Study of 8 subjects - volunteer medical students. Recruitment: Male medical students at Ninewells Hospital & Medical School, Dundee.

Male medical students will be e-mailed by the chief investigator.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Volunteers
Single group of healthy male medical students at Ninewells Hospital & Medical School, Dundee.
Device: shear wave elastography
ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 hours
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
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
max 2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Investigators

  • Principal Investigator: Graeme A McLeod, MBChB FRCA, NHS Tayside

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 19, 2013

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013AN01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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