The Diagnostic Value of Shear Wave Elastography

Not Applicable

Completed

• Conditions: Thyroid Nodule

• Registration Number: NCT02150772
• Lead Sponsor: University of Aarhus

Brief Summary

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

Aim:

To evaluate the diagnostic value of SWE in the pre-operative diagnosis of thyroid nodules in a tertiary surgical center.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-14
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-05-30
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-08
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

• Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery

Exclusion Criteria

• Not undergoing thyroid surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Elasticity Index	same day	Elasticity Index is obtained by SWE.

Trial Locations

Locations (1)

Øre-Næse-Halsafdeling H, Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark