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NCT02150772 Clinical Trial

The Diagnostic Value of Shear Wave Elastography

Thyroid Nodule Clinical Trial

Official title:
Shear Wave Elastography in the Diagnosis and Risk-stratification of Thyroid Nodules - a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02150772
Other study ID # SWE-diag 042014
Secondary ID
Status Completed
Phase N/A
First received April 14, 2014
Last updated April 8, 2016
Start date April 2014
Est. completion date March 2016

Study information
Verified date April 2016
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Etics KomiteeDenmark: Danish Dataprotiction Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 308
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Not undergoing thyroid surgery

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Shear Wave Elastography (SWE)

Locations
Country Name City State
Denmark Øre-Næse-Halsafdeling H, Aarhus University Hospital Aarhus C

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Elasticity Index Elasticity Index is obtained by SWE. same day No
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