The Observer Variation of Shear Wave Elastography

Intra- and Inter-observer Variation of Thyroid Shear Wave Elastography - a Variability Study

Background: The main goal of diagnosing thyroid nodules is to differentiate the few malignant from the large background of benign lesion. Currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic surgery is necessary. Therefore there is a need to develope the available diagnostic tools for the pre-operative diagnostic work-up of thyroid nodules.

The study will investigate a novel ultrasonographic technique called Shear Wave Elastography (SWE) in the pre-operative evaluation of thyroid nodules.

Hypothesis:

1) SWE is a precise tool for evaluation of thyroid nodules in terms of inter- and intra-observer reliability and day-to-day variation.

The study will be conducted as part of a larger PhD study, and an evaluation of the diagnostic value of thyroid SWE will be evaluated in a larger study.

Perspectives:

An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.

Study Overview

• Status: Completed
• Conditions: Thyroid Nodular Disease
• Intervention / Treatment: Device: Ultrasonographic Shear Wave Elastography

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Øre-Næse-Halsafdeling H, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with a thyroid nodule ≥1 cm in largest dimension (solitary or dominating nodule in multinodular goiter),
• Patients undergoing thyroid surgery.

Exclusion Criteria:

• Nodules located in the isthmus of the thyroid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Shear Wave Elastography; All included patients undergo a supplementary Shear Wave Elastographic scan	Device: Ultrasonographic Shear Wave Elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elasticity index	Elasticity Index is obtained by ultrasonographic Shear Wave Elastography performed by two investigators on the same day. The inter- and intra-observer variation and day-to-day variation is calculated	Repeat measures obtained on the same day (ten minutes to one hour between measurements), and measures obtained on a different day (one day to several weeks).

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 15, 2013
• First Submitted That Met QC Criteria: December 20, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Estimate): April 11, 2016
• Last Update Submitted That Met QC Criteria: April 8, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: SWE-var 112013