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NCT02462512 Clinical Trial

Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer

Thyroid Nodule Clinical Trial

— Elastography  

Official title:
Validation of Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02462512
Other study ID # SeoulStMary
Secondary ID
Status Recruiting
Phase N/A
First received April 20, 2015
Last updated October 30, 2016
Start date April 2015
Est. completion date August 2017

Study information
Verified date October 2016
Source Seoul St. Mary's Hospital
Contact Dong Jun Lim, Dr.
Phone 82-2-2258-6009
Email ldj6026@catholic.ac.kr
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive procedure and is subject to sampling and analysis uncertainties. Thus, improved, more reliable criteria for determining which nodule should be be aspirated are needed. Ultrasound elastography has been shown to be useful in the differential diagnosis of breast and prostate cancers. Ultrasound elastography also may discriminate malignant from benign nodule.

Description:

To prospectively evaluate the elastographic appearance of thyroid cancer and explore the potential sensitivity and specificity of elastography for differentiating benign and malignant tumors, with histopathologic analysis as the reference standard.

Recruitment information / eligibility
Status Recruiting
Enrollment 590
Est. completion date August 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- The patients with thyroid nodule who are supposed to take fine needle aspiration biopsy

Exclusion Criteria:

- The patients who do not want to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul St Mary's Hospital Seocho-gu Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dong Jun Lim

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Dighe M, Bae U, Richardson ML, Dubinsky TJ, Minoshima S, Kim Y. Differential diagnosis of thyroid nodules with US elastography using carotid artery pulsation. Radiology. 2008 Aug;248(2):662-9. doi: 10.1148/radiol.2482071758. Epub 2008 Jun 6. — View Citation

Lim DJ, Luo S, Kim MH, Ko SH, Kim Y. Interobserver agreement and intraobserver reproducibility in thyroid ultrasound elastography. AJR Am J Roentgenol. 2012 Apr;198(4):896-901. doi: 10.2214/AJR.11.7009. — View Citation

Luo S, Lim DJ, Kim Y. Objective ultrasound elastography scoring of thyroid nodules using spatiotemporal strain information. Med Phys. 2012 Mar;39(3):1182-9. doi: 10.1118/1.3679857. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic performance of elastography using in-vivo compression for detection of thyroid cancer Measuring ECI(Elasticity contrast index) of thyroid nodule by ultrasound elastography 1 year No
Secondary Determination of the parameters which could have influence on the diagnostic performance of ultrasound elastography using in-vivo compression Analysis of clinical characteristics of thyroid nodules and patients which are related to the diagnostic performance of ultrasound elastography One year No
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