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Clinical Trials/NCT02462512
NCT02462512UnknownNot Applicable

Validation of Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer

Dong Jun Lim1 site in 1 country590 target enrollmentStarted: April 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
590
Locations
1
Primary Endpoint
Diagnostic performance of elastography using in-vivo compression for detection of thyroid cancer

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Diagnostic performance of elastography using in-vivo compression for detection of thyroid cancer

Time Frame: 1 year

Measuring ECI(Elasticity contrast index) of thyroid nodule by ultrasound elastography

Secondary Outcomes

  • Determination of the parameters which could have influence on the diagnostic performance of ultrasound elastography using in-vivo compression(One year)

Investigators

Sponsor
Dong Jun Lim
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dong Jun Lim

SeoulStMary

Seoul St. Mary's Hospital

Study Sites (1)

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