The Observer Variation of Shear Wave Elastography

NCT02022319 | Completed DMC

• 1 other identifier: SWE-var 112013
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodular Disease

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (1)

Shear Wave Elastography

OTHER

All included patients undergo a supplementary Shear Wave Elastographic scan

Device: Ultrasonographic Shear Wave Elastography

Interventions

Ultrasonographic Shear Wave Elastography DEVICE

Shear Wave Elastography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a thyroid nodule ≥1 cm in largest dimension (solitary or dominating nodule in multinodular goiter),
• Patients undergoing thyroid surgery.

You may not qualify if:

• Nodules located in the isthmus of the thyroid

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Øre-Næse-Halsafdeling H, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 15, 2013
• First Posted: December 27, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

DK (1)