Thyroid NoduleNCT02150772
The Diagnostic Value of Shear Wave Elastography
A study testing Shear Wave Elastography (SWE) in people with Thyroid Nodule, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Shear Wave Elastography (SWE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery
Who cannot join
- Not undergoing thyroid surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Øre-Næse-Halsafdeling H, Aarhus University Hospital
Aarhus C, 8000
About this study
Official title: Shear Wave Elastography in the Diagnosis and Risk-stratification of Thyroid Nodules - a Prospective Study
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.
Read more
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.
- Conditions
- Thyroid Nodule
- Being tested
- Shear Wave Elastography (SWE)
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave Elastography (SWE)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Shear Wave Elastography | Other | All included patients have SWE performed Receives: Procedure: Shear Wave Elastography (SWE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity Index
Elasticity Index is obtained by SWE.
Measured: same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Zøylner Rubeck, University of Aarhus
- Investigators
- Kristine Z Rubeck, MD, Principal investigator, Dep. of otorhinolaryngology, Aarhus University HoapitalViveque E Nielsen, MD PhD, Study director, Dep. of oto-rhinolarymgology and Head and Neck surgery, Aarhus Universtity HospitalSteen J Bonnema, PhD, DMSc, Study chair, Dep. of Endocrinology, Odense University HospitalMarie Louise Jespersen, MD, Study chair, Dep. of Pathology, Aarhus University HospitalPeer Christiansen, DMSc, Study chair, Dep. og General Surgery, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150772
- Sponsor's protocol ID
- SWE-diag 042014
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2014
- Last updated
- 11 Apr 2016
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Wave Elastography in the Diagnosis and Risk-stratification of Thyroid Nodules - a Prospective Study
- ClinicalTrials.gov ID
- NCT02150772
- Acronym / sponsor ID
- SWE-diag 042014
- Conditions
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shear Wave Elastography | Other | Procedure: Shear Wave Elastography (SWE)All included patients have SWE performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery
Key exclusion criteria (1 listed)
- Not undergoing thyroid surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear Wave Elastography (SWE) | Procedure or surgery | Shear Wave Elastography |
Primary outcome
Elasticity Index
Time frame: same day
Elasticity Index is obtained by SWE.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Derived from this study: PubMed 33713190Bakkegaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear Wave Elastography (SWE) in people with Thyroid Nodule, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elasticity Index (time frame: same day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.