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The Observer Variation of Shear Wave Elastography

Primary Purpose

Thyroid Nodular Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ultrasonographic Shear Wave Elastography
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Nodular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Øre-Næse-Halsafdeling H, Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Shear Wave Elastography

Arm Description

All included patients undergo a supplementary Shear Wave Elastographic scan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2013
Last Updated
April 8, 2016
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02022319
Brief Title
The Observer Variation of Shear Wave Elastography
Official Title
Intra- and Inter-observer Variation of Thyroid Shear Wave Elastography - a Variability Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodular Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shear Wave Elastography
Arm Type
Other
Arm Description
All included patients undergo a supplementary Shear Wave Elastographic scan
Intervention Type
Device
Intervention Name(s)
Ultrasonographic Shear Wave Elastography
Primary Outcome Measure Information:
Title
Elasticity index
Description
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
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Øre-Næse-Halsafdeling H, Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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The Observer Variation of Shear Wave Elastography

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