Elastography in Thyroid Nodules

Sponsor
Castilla-León Health Service (Other)
Overall Status
Completed
CT.gov ID
NCT01102127
Collaborator
(none)
128
1
7
18.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Elastography

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 Design

Study Type:
Observational
Actual Enrollment :
128 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Goiter

Patients with nodular goiter

Device: Elastography
Performance of US, elastography and FNA.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of elastography for thyroid cancer [1 day]

    Sensitivity, specifity, predictive values

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01102127
Other Study ID Numbers:
  • TNUS122009
First Posted:
Apr 13, 2010
Last Update Posted:
May 25, 2011
Last Verified:
Apr 1, 2011

Study Results

No Results Posted as of May 25, 2011