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The Observer Variation of Shear Wave Elastography

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University of Aarhus

Status

Completed

Conditions

Thyroid Nodular Disease

Treatments

Device: Ultrasonographic Shear Wave Elastography

Study type

Interventional

Funder types

Other

Identifiers

NCT02022319
SWE-var 112013

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

72 participants in 1 patient group

Shear Wave Elastography
Other group
Description:
All included patients undergo a supplementary Shear Wave Elastographic scan
Treatment:
Device: Ultrasonographic Shear Wave Elastography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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