Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer

NCT02462512 | Unknown

• 1 other identifier: SeoulStMary
• Study Type: observational
• Target: 590
• Locations: 1 country
• Sites: 1

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.

Conditions

Elastography; Thyroid Nodule

Keywords

Elastography; Thyroid nodule

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  One year

Study Arms (1)

FNAB of Thyroid nodule

The Patients with thyroid nodule who are scheduled for FNAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with thyroid nodule who visit tertiary hospital for fine needle aspiration biopsy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dong Jun Lim: lead

Study Sites (1)

Seoul St Mary's Hospital

Seocho-gu, Seoul, 137-701, South Korea

RECRUITING

Related 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.

  PMID: 18539888 BACKGROUND

• 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.

  PMID: 22380349 RESULT

• 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.

  PMID: 22451558 RESULT

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Dong Jun Lim, Dr.

  Associate Professor, Head, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Min Hee Kim, Dr.

  Clinical Assistant Professor, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea

  STUDY DIRECTOR

Central Study Contacts

Dong Jun Lim, Dr.

CONTACT

82-2-2258-6009; ldj6026@catholic.ac.kr

Kwanhoon Jo, Dr.

CONTACT

82-2-2258-6340; lovi@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: SeoulStMary

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: June 4, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2017
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

KR (1)