Back to resultsThe Diagnostic Value of Shear Wave Elastography
Primary Purpose
Thyroid Nodule
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Shear Wave Elastography (SWE)
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Nodule
Eligibility Criteria
Inclusion Criteria:
- Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery
Exclusion Criteria:
- Not undergoing thyroid surgery
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 have SWE performed
Outcomes
Primary Outcome Measures
Elasticity Index
Elasticity Index is obtained by SWE.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02150772
Brief Title
The Diagnostic Value of Shear Wave Elastography
Official Title
Shear Wave Elastography in the Diagnosis and Risk-stratification of Thyroid Nodules - a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shear Wave Elastography
Arm Type
Other
Arm Description
All included patients have SWE performed
Intervention Type
Procedure
Intervention Name(s)
Shear Wave Elastography (SWE)
Primary Outcome Measure Information:
Title
Elasticity Index
Description
Elasticity Index is obtained by SWE.
Time Frame
same day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery
Exclusion Criteria:
Not undergoing thyroid surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Z Rubeck, MD
Organizational Affiliation
Dep. of otorhinolaryngology, Aarhus University Hoapital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Viveque E Nielsen, MD PhD
Organizational Affiliation
Dep. of oto-rhinolarymgology and Head and Neck surgery, Aarhus Universtity Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steen J Bonnema, PhD, DMSc
Organizational Affiliation
Dep. of Endocrinology, Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marie Louise Jespersen, MD
Organizational Affiliation
Dep. of Pathology, Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peer Christiansen, DMSc
Organizational Affiliation
Dep. og General Surgery, Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Øre-Næse-Halsafdeling H, Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
33713190
Citation
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.
Results Reference
derived
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The Diagnostic Value of Shear Wave Elastography
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