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

Thyroid Nodules Clinical Trial

Official title:

Evaluation of Shear Wave Elastography in the Diagnosis and Management of Thyroid Nodules in Chinese Population: A Prospective, Multicenter Study

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT02937467
• Other study ID #: SHSY-IEC-3.0/15-78/01
• Status: Available
• Phase: N/A
• First received: October 15, 2016
• Last updated: October 15, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Beijing Cancer Hospital
• Contact: liu wenying, Doctor
• Phone: 86-10-88196941
• Email: liuwy23[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Expanded Access

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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:

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

Study Design

N/A

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule
• Thyroid Nodules

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Shanghai 10th People's Hospital

References & Publications (5)

Berg WA, Cosgrove DO, Doré CJ, Schäfer 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. — View Citation

Monpeyssen H, Tramalloni J, Poirée S, Hélénon 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. Review. — View Citation

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):407-12. doi: 10.1016/j.ejrad.2014.11.019. Epub 2014 Nov 27. — View Citation

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 — View Citation

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. — View Citation