Elastography in Thyroid Nodules

Thyroid Cancer Clinical Trial

Official title:

Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102127
• Other study ID #: TNUS122009
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: May 24, 2011
• Start date: February 2010
• Est. completion date: September 2010

Study information

• Verified date: April 2011
• Source: Castilla-León Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Goiter, Nodular
• Nodular Goiter
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Device:
• Elastography
Performance of US, elastography and FNA.

Locations

Country	Name	City	State
Spain	Complejo Asistencial de León	León

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Dighe M, Kim J, Luo S, Kim Y. Utility of the ultrasound elastographic systolic thyroid stiffness index in reducing fine-needle aspirations. J Ultrasound Med. 2010 Apr;29(4):565-74. — View Citation

Friedrich-Rust M, Sperber A, Holzer K, Diener J, Grünwald F, Badenhoop K, Weber S, Kriener S, Herrmann E, Bechstein WO, Zeuzem S, Bojunga J. Real-time elastography and contrast-enhanced ultrasound for the assessment of thyroid nodules. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):602-9. doi: 10.1055/s-0029-1237701. Epub 2009 Oct 23. — View Citation

Luo S, Kim EH, Dighe M, Kim Y. Screening of thyroid nodules by ultrasound elastography using diastolic strain variation. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:4420-3. doi: 10.1109/IEMBS.2009.5332744. — View Citation

Tonacchera M, Pinchera A, Vitti P. Assessment of nodular goitre. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):51-61. doi: 10.1016/j.beem.2009.08.008. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of elastography for thyroid cancer	Sensitivity, specifity, predictive values	1 day	No