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AvailableNCT02937467Updated Oct 18, 2016

The Multi-Center Study of Shear Wave Elastography on Thyroid Nodules

An expanded access record providing SWE in Thyroid Nodules, sponsored by Peking University Cancer Hospital & Institute. Available. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-18.

Sponsored by Peking University Cancer Hospital & Institute · Expanded access

Study type
Expanded access
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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

  1. Main purpose

    1. to assess the performance of SWE for identification of benign and malignant thyroid nodules in multicenter study;
    2. calculate the optimal cutoff value for each parameter in multicenter study
  2. Secondary purpose to evaluate the application value of SWE for uncertain nodules by FNA.
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Conditions studied

  • Thyroid Nodules

Keywords

  • SWE
  • diagnosis
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In context

Thyroid Nodule

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

Browse Thyroid Nodule studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 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 to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. the size of the lesion is between 0.5~4cm
  2. the solid components in the lesion>50%;
  3. all patients perform FNA or surgery in one month after SWE examination

Exclusion criteria

Exclusion Criteria:

  1. patients who are unwilling or unable to provide informed consent
  2. Woman who is pregnant or breastfeeding;
  3. Thyroid nodules with calcified which is beyond 1/2 diameter of lesion
  4. patients who have history of surgery、FNA or thermal ablation in ipsilateral thyroid
  5. patients who have serious cardiopulmonary diseases
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Access details

Study type
Expanded access

Available treatment

  • DeviceSWE

    a novel ultrasound-based elastographic method, a new real-time, quantitative, operator-independent, and reproducible technique

06

Where to request access

No study locations are listed for this record.

07

References and documents

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 22282182 ↗
  • Monpeyssen 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 23623210 ↗
  • Xu 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. Erratum In: Radiology. 2015 Jan;274(1):307. PubMed 24689885 ↗
  • Park 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 25533720 ↗
  • Shiina 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 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
NCT02937467
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborators
Shanghai 10th People's Hospital
Responsible party
Kun Yan (chief director, Peking University Cancer Hospital & Institute) — Principal investigator
First posted
Oct 18, 2016
Start date
Dec 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Oct 18, 2016

Study contacts

liu wenying, Doctor
Contact
liuwy23@sina.com
86-10-88196941
liu boji, Doctor
Contact
jxjj1990@126.com
86-13641668014
yan kun, Doctor
principal investigator · Peking University Cancer Hospital & Institute
xu huixiong, Doctor
principal investigator · Shanghai 10th People's Hospital
View the source record on ClinicalTrials.gov ↗

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