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CompletedNCT02150772Updated Apr 11, 2016

The Diagnostic Value of Shear Wave Elastography

An interventional study of Shear Wave Elastography (SWE) in Thyroid Nodule, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-11.

Sponsored by University of Aarhus · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
308
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Background: The main goal when diagnosing thyroid nodules, is to differentiate the few malignant from the overwhelming background of benign nodules. Currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic thyroid surgery is necessary. Therefore, there is a need to develope the diagnostic tools for 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.

Aim:

To evaluate the diagnostic value of SWE in the pre-operative diagnosis of thyroid nodules in a tertiary surgical center.

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.

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Conditions studied

  • Thyroid Nodule

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03

In context

Thyroid Nodule

200 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.

This study's enrollment of 308 is above the median of 81 across 118 interventional studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery

Exclusion criteria

Exclusion Criteria:

  • Not undergoing thyroid surgery
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
308 participants (actual)

Study arms

  • Other
    Shear Wave Elastography

    All included patients have SWE performed

    Procedure: Shear Wave Elastography (SWE)

Interventions

  • ProcedureShear Wave Elastography (SWE)
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What researchers measure

Primary outcomes

  1. Elasticity Index

    Elasticity Index is obtained by SWE.

    Time frame: same day

07

Study locations

1 site
  • Øre-Næse-Halsafdeling H, Aarhus University Hospital
    Aarhus C, 8000, Denmark
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References and documents

Publications

  • Bakkegaard P, Londero SC, Bonnema SJ, Nielsen VE, Jespersen ML, Swan KZ. Risk-stratification of thyroid nodules examined by 18FDG-PET/CT while ensuring congruity between imaging and histopathological localization. Eur Arch Otorhinolaryngol. 2021 Dec;278(12):4979-4985. doi: 10.1007/s00405-021-06733-5. Epub 2021 Mar 13. PubMed 33713190 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02150772
Lead sponsor
University of Aarhus
Responsible party
Kristine Zøylner Rubeck (MD, University of Aarhus) — Principal investigator
First posted
May 30, 2014
Start date
Apr 2014
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Apr 11, 2016

Study contacts

Kristine Z Rubeck, MD
principal investigator · Dep. of otorhinolaryngology, Aarhus University Hoapital
Viveque E Nielsen, MD PhD
study director · Dep. of oto-rhinolarymgology and Head and Neck surgery, Aarhus Universtity Hospital
Steen J Bonnema, PhD, DMSc
study chair · Dep. of Endocrinology, Odense University Hospital
Marie Louise Jespersen, MD
study chair · Dep. of Pathology, Aarhus University Hospital
Peer Christiansen, DMSc
study chair · Dep. og General Surgery, Aarhus University Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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