The Observer Variation of Shear Wave Elastography | NCT02022319

Studies
The Observer Variation of Shear Wave Elastography

NCT02022319

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Apr 11, 2016Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Thyroid Nodular Disease

Interventions

Ultrasonographic Shear Wave Elastography

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 15, 2013

First Submission Date that Met QC Criteria

Dec 20, 2013

First Posted Date

Dec 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2016

Last Update Posted Date

Apr 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kristine Zøylner Rubeck, MD, University of AarhusPrincipal Investigator

Lead Sponsor

University of AarhusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shear Wave Elastography	Other	All included patients undergo a supplementary Shear Wave Elastographic scan	Device: Ultrasonographic Shear Wave Elastography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonographic Shear Wave Elastography	Device		Shear Wave Elastography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Øre-Næse-Halsafdeling H, Aarhus University Hospital		Aarhus C		8000	Denmark