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Elastography in Thyroid Nodules

This study has been completed.
Sponsor:
Information provided by:
Castilla-León Health Service
ClinicalTrials.gov Identifier:
NCT01102127
First received: April 12, 2010
Last updated: May 24, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Nodular Goiter
Thyroid Cancer
 Device: Elastography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.

Resource links provided by NLM:

Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Castilla-León Health Service:

Primary Outcome Measures:
  • Diagnostic accuracy of elastography for thyroid cancer [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Sensitivity, specifity, predictive values


Biospecimen Retention:   Samples Without DNA

Thyroid cells


Enrollment: 128
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Goiter
Patients with nodular goiter
 Device: Elastography
Performance of US, elastography and FNA.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

General population with nodular goiter.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102127

Locations
Spain
Complejo Asistencial de León
León, Spain, 24008
Sponsors and Collaborators
Castilla-León Health Service
Investigators
Principal Investigator: Alfonso Vidal-Casariego, MD Complejo Asistencial de León
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alfonso Vidal-Casariego, Complejo Asistencial de León
ClinicalTrials.gov Identifier: NCT01102127     History of Changes
Other Study ID Numbers: TNUS122009
Study First Received: April 12, 2010
Last Updated: May 24, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Castilla-León Health Service:
elastography
thyroid nodule
fine-needle aspiration

Additional relevant MeSH terms:
Thyroid Neoplasms
Goiter
Goiter, Nodular
Thyroid Diseases
Thyroid Nodule
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013