The Diagnostic Value of Shear Wave Elastography
Shear Wave Elastography in the Diagnosis and Risk-stratification of Thyroid Nodules - a Prospective Study
1 other identifier
interventional
308
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 11, 2016
April 1, 2016
1.9 years
April 14, 2014
April 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Elasticity Index
Elasticity Index is obtained by SWE.
same day
Study Arms (1)
Shear Wave Elastography
OTHERAll included patients have SWE performed
Interventions
Eligibility Criteria
You may qualify if:
- Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery
You may not qualify if:
- Not undergoing thyroid surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Øre-Næse-Halsafdeling H, Aarhus University Hospital
Aarhus C, 8000, Denmark
Related Publications (1)
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.
PMID: 33713190DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristine Z Rubeck, MD
Dep. of otorhinolaryngology, Aarhus University Hoapital
- STUDY DIRECTOR
Viveque E Nielsen, MD PhD
Dep. of oto-rhinolarymgology and Head and Neck surgery, Aarhus Universtity Hospital
- STUDY CHAIR
Steen J Bonnema, PhD, DMSc
Dep. of Endocrinology, Odense University Hospital
- STUDY CHAIR
Marie Louise Jespersen, MD
Dep. of Pathology, Aarhus University Hospital
- STUDY CHAIR
Peer Christiansen, DMSc
Dep. og General Surgery, Aarhus University Hospital
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
April 14, 2014
First Posted
May 30, 2014
Study Start
April 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 11, 2016
Record last verified: 2016-04