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Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer

NCT ID: NCT02462512

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

590 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Elastography Thyroid Nodule

Keywords

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Elastography Thyroid nodule

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FNAB of Thyroid nodule

The Patients with thyroid nodule who are scheduled for FNAB

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong Jun Lim

OTHER

Sponsor Role lead

Responsible Party

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Dong Jun Lim

SeoulStMary

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dong Jun Lim, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Min Hee Kim, Dr.

Role: STUDY_DIRECTOR

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

Locations

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Seoul St Mary's Hospital

Seocho-gu, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Jun Lim, Dr.

Role: CONTACT

Phone: 82-2-2258-6009

Email: [email protected]

Kwanhoon Jo, Dr.

Role: CONTACT

Phone: 82-2-2258-6340

Email: [email protected]

Facility Contacts

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Dong Jun Lim, Dr.

Role: primary

Kwanhoon Jo, Dr.

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 18539888 (View on PubMed)

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.

Reference Type RESULT
PMID: 22380349 (View on PubMed)

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.

Reference Type RESULT
PMID: 22451558 (View on PubMed)

Other Identifiers

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SeoulStMary

Identifier Type: -

Identifier Source: org_study_id