Elastography in Thyroid Nodules

Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.

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Key information

Conditions

Nodular Goiter Endocrine Gland Neoplasms Endocrine System Diseases Goiter Goiter, Nodular Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Asistencial de León

León, 24008, Spain

About this study

Aims:

Primary aim: to evaluate the diagnostic accuracy of elastography in thyroid nodules from a low-risk of thyroid cancer population.

Secondary aim: to evaluate the usefulness of elastography to detect carcinomas in thyroid nodules with indeterminate FNA.

Patient selection:

Inclusion criteria

Age > 18 yr.
Recruitment in Endocrinology Clinics.
Nodular goiter.
Multinodular goiter with dominant nodule > 1 cm.

Exclusion criteria

Toxic nodules
Non-accessible nodules to US or FNA
Cystic nodules
Nodules with calcifications in egg rind
Contraindication for FNA

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18 yr.
Recruitment in Endocrinology surgery.
Nodular goiter.
Multinodular goiter with dominant nodule > 1 cm.

Exclusion criteria

Toxic nodules
Non-accessible nodules to US or FNA
Cystic nodules
Nodules with calcifications in egg rind
Contraindication of FNA

Treatment and study plan

Elastography

Device

Performance of US, elastography and FNA.

Primary outcomes

Diagnostic accuracy of elastography for thyroid cancer

Time frame: 1 day

Sensitivity, specifity, predictive values

Sponsors and collaborators

Lead sponsor

Castilla-León Health Service

Other

Registry information

Official study title

Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Apr 13, 2010
Registry last updated: May 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed