Thyroid Nodular Disease Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 72 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Øre-Næse-Halsafdeling H, Aarhus University Hospital | Aarhus C |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aarhus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | No |