Elastography in Thyroid Nodules

May 24, 2011 updated by: Castilla-León Health Service

Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • León, Spain, 24008
        • Complejo Asistencial de León

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

General population with nodular goiter.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Goiter
Patients with nodular goiter
Device: Elastography
Performance of US, elastography and FNA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of elastography for thyroid cancer
Time Frame: 1 day
Sensitivity, specifity, predictive values
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-León Health Service

Investigators

  • Principal Investigator: Alfonso Vidal-Casariego, MD, Complejo Asistencial de León

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

May 25, 2011

Last Update Submitted That Met QC Criteria

May 24, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNUS122009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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