Elastography in Thyroid Nodules

Completed

• Conditions: Thyroid Cancer; Nodular Goiter
• Interventions: Device: Elastography

• Registration Number: NCT01102127
• Lead Sponsor: Castilla-León Health Service

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-04
• Last Update Submitted: 2011-05-24
• Last Update Posted: 2011-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Goiter	Elastography	Patients with nodular goiter

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of elastography for thyroid cancer	1 day	Sensitivity, specifity, predictive values

Trial Locations

Locations (1)

Complejo Asistencial de León; 🇪🇸 León, Spain