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

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

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02937467
Enrollment
Unknown
Registered
2016-10-18
Start date
2016-12-31
Completion date
2018-12-31
Last updated
2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodules

Keywords

SWE, diagnosis

Brief 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.

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.

Interventions

DEVICESWE

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

Sponsors

Shanghai 10th People's Hospital
CollaboratorOTHER
Peking University Cancer Hospital & Institute
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

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

Contacts

Primary Contactliu wenying, Doctor
liuwy23@sina.com86-10-88196941
Backup Contactliu boji, Doctor
jxjj1990@126.com86-13641668014

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026