Elastography in Thyroid Nodules

Castilla-León Health Service

Status: Completed

Conditions: Nodular Goiter; Thyroid Cancer

Treatments: Device: Elastography

Study type: Observational

Funder types: Other

Identifiers

NCT01102127

TNUS122009

Details and patient eligibility

About

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.

Full 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

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

128 participants in 1 patient group

Goiter

Description:

Patients with nodular goiter

Treatment:

Device: Elastography