Clinical Trial: Elastography in Thyroid Nodules

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.

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 Summary:

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

Sponsor: Castilla-León Health Service

Current Primary Outcome: Diagnostic accuracy of elastography for thyroid cancer [ Time Frame: 1 day ]

Sensitivity, specifity, predictive values


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Castilla-León Health Service

Dates:
Date Received: April 12, 2010
Date Started: February 2010
Date Completion:
Last Updated: May 24, 2011
Last Verified: April 2011