The Observer Variation of Shear Wave Elastography

NCT ID: NCT02022319

Last Updated: 2016-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Nodular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Shear Wave Elastography

All included patients undergo a supplementary Shear Wave Elastographic scan

Group Type OTHER

Ultrasonographic Shear Wave Elastography

Intervention Type DEVICE

Interventions

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Ultrasonographic Shear Wave Elastography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Kristine Zøylner Rubeck

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Øre-Næse-Halsafdeling H, Aarhus University Hospital

Aarhus C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SWE-var 112013

Identifier Type: -

Identifier Source: org_study_id

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