Clinical trial NCT02462512: Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer
Official title: Validation of Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elastography
Thyroid Nodule
Keywords: Elastography
Thyroid nodule
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with thyroid nodule who visit tertiary hospital for fine needle aspiration biopsy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic performance of elastography using in-vivo compression for detection of thyroid cancer
timeFrame: 1 year
Secondary outcomes:
measure: Determination of the parameters which could have influence on the diagnostic performance of ultrasound elastography using in-vivo compression
timeFrame: One year
Other outcomes:
Locations:
city: Seocho-gu
country: Korea, Republic of
facility: Seoul St Mary's Hospital
state: Seoul
Study officials:
affiliation: Associate Professor, Head, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea
name: Dong Jun Lim, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Assistant Professor, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea
name: Min Hee Kim, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.