Thyroid NodulesNCT02937467
The Multi-Center Study of Shear Wave Elastography on Thyroid Nodules
A study testing SWE in people with Thyroid Nodules, run by Peking University Cancer Hospital & Institute.
Trial summary
The incidence rates of thyroid cancers have increased in the past decade. Additionally, up to 68% of people have thyroid nodules. Consequently, a precise evaluation of thyroid nodules is very important and can avoid unnecessary biopsy of benign nodules. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Nodules
- What is being tested?
- SWE
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- Phase
- Expanded access
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the size of the lesion is between 0.5～4cm
- the solid components in the lesion>50%；
- all patients perform FNA or surgery in one month after SWE examination
Who cannot join
- patients who are unwilling or unable to provide informed consent
- Woman who is pregnant or breastfeeding;
- Thyroid nodules with calcified which is beyond 1/2 diameter of lesion
- patients who have history of surgery、FNA or thermal ablation in ipsilateral thyroid
- patients who have serious cardiopulmonary diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Shear Wave Elastography in the Diagnosis and Management of Thyroid Nodules in Chinese Population: A Prospective, Multicenter Study
The incidence rates of thyroid cancers have increased in the past decade. Additionally, up to 68% of people have thyroid nodules. Consequently, a precise evaluation of thyroid nodules is very important and can avoid unnecessary biopsy of benign nodules. Shear wave elastography(SWE), a novel ultrasound-based elastographic method, is a new real-time, quantitative, operator-independent, and reproducible technique. Briefly, shear wave elastography uses a radiation force produced by an ultrasonic beam to stress tissues and ultrafast sonographic tracking techniques to measure the speed of shear waves. Based on the Young modulus formula, tissue elasticity can be derived from the shear wave propagation speed, and a real-time color-coded elastogram can be displayed, showing softer tissue in blue and stiffer tissue in red.
There are lots of research confirmed that SWE has a certain value in the diagnosis of thyroid carcinoma. These studies include prospective studies and retrospective studies, but both belong to a single center study. It has not been applied to the study of the multicenter of thyroid disease.
The main purpose of the study is to assess the performance of SWE for identification of benign and malignant thyroid nodules and calculate the optimal cutoff value for each parameter in multicenter study; the secondary purpose is to evaluate the application value of SWE for uncertain nodules by FNA.
Read the detailed description
SWE can prove the diagnostic performance in the differentiation of benign and malignant thyroid lesions
- Main purpose
- to assess the performance of SWE for identification of benign and malignant thyroid nodules in multicenter study;
- calculate the optimal cutoff value for each parameter in multicenter study
- Secondary purpose to evaluate the application value of SWE for uncertain nodules by FNA.
- Conditions
- Thyroid Nodules
- Being tested
- SWE
- Keywords
- SWE, diagnosis
- Medical subject headings
- Thyroid Nodule, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWEDevice
a novel ultrasound-based elastographic method, a new real-time, quantitative, operator-independent, and reproducible technique
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thyroid NodulesStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital
- Responsible party
- Principal investigator, Kun Yan, Peking University Cancer Hospital & Institute
- Investigators
- yan kun, Doctor, Principal investigator, Peking University Cancer Hospital & Institutexu huixiong, Doctor, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937467
- Sponsor's protocol ID
- SHSY-IEC-3.0/15-78/01
- Status last verified
- Oct 2016
- First submitted
- 15 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
Publications
Berg WA, Cosgrove DO, Dore CJ, Schafer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640.
PubMed 22282182Monpeyssen H, Tramalloni J, Poiree S, Helenon O, Correas JM. Elastography of the thyroid. Diagn Interv Imaging. 2013 May;94(5):535-44. doi: 10.1016/j.diii.2013.01.023. Epub 2013 Apr 25.
PubMed 23623210Xu JM, Xu XH, Xu HX, Zhang YF, Zhang J, Guo LH, Liu LN, Liu C, Zheng SG. Conventional US, US elasticity imaging, and acoustic radiation force impulse imaging for prediction of malignancy in thyroid nodules. Radiology. 2014 Aug;272(2):577-86. doi: 10.1148/radiol.14132438. Epub 2014 Apr 2.
PubMed 24689885Park AY, Son EJ, Han K, Youk JH, Kim JA, Park CS. Shear wave elastography of thyroid nodules for the prediction of malignancy in a large scale study. Eur J Radiol. 2015 Mar;84(3):407-412. doi: 10.1016/j.ejrad.2014.11.019. Epub 2014 Nov 27.
PubMed 25533720Shiina T, Nightingale KR, Palmeri ML, Hall TJ, Bamber JC, Barr RG, Castera L, Choi BI, Chou YH, Cosgrove D, Dietrich CF, Ding H, Amy D, Farrokh A, Ferraioli G, Filice C, Friedrich-Rust M, Nakashima K, Schafer F, Sporea I, Suzuki S, Wilson S, Kudo M. WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 1: basic principles and terminology. Ultrasound Med Biol. 2015 May;41(5):1126-47. doi: 10.1016/j.ultrasmedbio.2015.03.009. Epub 2015 Mar 21.
PubMed 25805059
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Shear Wave Elastography in the Diagnosis and Management of Thyroid Nodules in Chinese Population: A Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT02937467
- Acronym / sponsor ID
- SHSY-IEC-3.0/15-78/01
- Conditions
- Thyroid Nodules
- Keywords
- SWE, diagnosis
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Oct 2016 (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.
The incidence rates of thyroid cancers have increased in the past decade. Additionally, up to 68% of people have thyroid nodules. Consequently, a precise evaluation of thyroid nodules is very important and can avoid unnecessary biopsy of benign nodules. Shear wave elastography(SWE), a novel ultrasound-based elastographic method, is a new real-time, quantitative, operator-independent, and reproducible technique. Briefly, shear wave elastography uses a radiation force produced by an ultrasonic beam to stress tissues and ultrafast sonographic tracking techniques to measure the speed of shear waves. Based on the Young modulus formula, tissue elasticity can be derived from the shear wave propagation speed, and a real-time color-coded elastogram can be displayed, showing softer tissue in blue and stiffer tissue in red.
There are lots of research confirmed that SWE has a certain value in the diagnosis of thyroid carcinoma. These studies include prospective studies and retrospective studies, but both belong to a single center study. It has not been applied to the study of the multicenter of thyroid disease.
The main purpose of the study is to assess the performance of SWE for identification of benign and malignant thyroid nodules and calculate the optimal cutoff value for each parameter in multicenter study; the secondary purpose is to evaluate the application value of SWE for uncertain nodules by FNA.
Detailed description
SWE can prove the diagnostic performance in the differentiation of benign and malignant thyroid lesions
- Main purpose
- to assess the performance of SWE for identification of benign and malignant thyroid nodules in multicenter study;
- calculate the optimal cutoff value for each parameter in multicenter study
- Secondary purpose to evaluate the application value of SWE for uncertain nodules by FNA.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the size of the lesion is between 0.5～4cm
- the solid components in the lesion>50%；
- all patients perform FNA or surgery in one month after SWE examination
Key exclusion criteria (5 listed)
- patients who are unwilling or unable to provide informed consent
- Woman who is pregnant or breastfeeding;
- Thyroid nodules with calcified which is beyond 1/2 diameter of lesion
- patients who have history of surgery、FNA or thermal ablation in ipsilateral thyroid
- patients who have serious cardiopulmonary diseases
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 |
|---|---|---|
| SWEa novel ultrasound-based elastographic method, a new real-time, quantitative, operator-independent, and reproducible technique | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Background: PubMed 22282182Berg WA, Cosgrove DO, Dore CJ, Schafer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640.
- Background: PubMed 23623210Monpeyssen H, Tramalloni J, Poiree S, Helenon O, Correas JM. Elastography of the thyroid. Diagn Interv Imaging. 2013 May;94(5):535-44. doi: 10.1016/j.diii.2013.01.023. Epub 2013 Apr 25.
- Background: PubMed 24689885Xu JM, Xu XH, Xu HX, Zhang YF, Zhang J, Guo LH, Liu LN, Liu C, Zheng SG. Conventional US, US elasticity imaging, and acoustic radiation force impulse imaging for prediction of malignancy in thyroid nodules. Radiology. 2014 Aug;272(2):577-86. doi: 10.1148/radiol.14132438. Epub 2014 Apr 2.
- Background: PubMed 25533720Park AY, Son EJ, Han K, Youk JH, Kim JA, Park CS. Shear wave elastography of thyroid nodules for the prediction of malignancy in a large scale study. Eur J Radiol. 2015 Mar;84(3):407-412. doi: 10.1016/j.ejrad.2014.11.019. Epub 2014 Nov 27.
- Results publication: PubMed 25805059Shiina T, Nightingale KR, Palmeri ML, Hall TJ, Bamber JC, Barr RG, Castera L, Choi BI, Chou YH, Cosgrove D, Dietrich CF, Ding H, Amy D, Farrokh A, Ferraioli G, Filice C, Friedrich-Rust M, Nakashima K, Schafer F, Sporea I, Suzuki S, Wilson S, Kudo M. WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 1: basic principles and terminology. Ultrasound Med Biol. 2015 May;41(5):1126-47. doi: 10.1016/j.ultrasmedbio.2015.03.009. Epub 2015 Mar 21.
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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.
yan kun, Doctor principal investigator
Peking University Cancer Hospital & Institute
xu huixiong, Doctor principal investigator
Shanghai 10th People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing SWE in people with Thyroid Nodules, run by Peking University Cancer Hospital & Institute.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liu wenying, Doctor (86-10-88196941, liuwy23@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937467, which also lists 5 linked publications.
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 18 Oct 2016.