Investigation of Ultrasound Elastographic Techniques in Soft Tissue Pathology

February 19, 2015 updated by: The Leeds Teaching Hospitals NHS Trust

Ultrasound (US)tissue elastography has recently been found to have a number of clinical applications in the assessment of soft tissue disease for example, in breast and thyroid pathology. There are few current studies exploring its use in musculoskeletal pathology, particularly a new technique called sheer wave ultrasound elastography (SWUE).

Magnetic Resonance (MR) elastography has shown wide reaching applications in orthopaedics, sports medicine and rheumatology and SWUE may have the potential to also demonstrate clinical effectiveness in these areas.

Our aim is to explore the effectiveness of this technique in the assessment of musculoskeletal pathology.

Participants will be recruited through current referral protocols and would undergo an additional elastographic investigation in addition to their standard US examination. This investigation will be conducted within the musculoskeletal US department at Chapel Allerton Hospital by trained musculoskeletal specialists. The study will be conducted over a period of approximately 24 months with quarterly review during this time.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

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

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Musculoskeletal US department at Chapel Allerton Hospital

Description

Inclusion Criteria:

  • Have clinical symptoms and signs of soft tissue pathology
  • Be able to give consent
  • Be over 16 years of age

Exclusion Criteria:

  • Unable to give consent
  • 16years of age or less
  • Multifactorial soft tissue pathology

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SWUE
Procedure: SWUE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical effectiveness of Sheer wave ultrasound elastography (SWUE) in the assessment of soft tissue pathology
Time Frame: Baseline to 24 months
Ability of SWUE to accurately detect soft tissue pathology when compared with standard ultrasound techniques.
Baseline to 24 months

Collaborators and Investigators

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

Sponsor

The Leeds Teaching Hospitals NHS Trust

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

July 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • RD13/10834
  • 14845 (Other Identifier: UKCRN)

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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