Clinical trial NCT01102127: Elastography in Thyroid Nodules
Official title: Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nodular Goiter
Thyroid Cancer
Keywords: elastography
thyroid nodule
fine-needle aspiration
Lead sponsor: Castilla-León Health Service
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population with nodular goiter.

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 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 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

Primary outcomes:
measure: Diagnostic accuracy of elastography for thyroid cancer
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: León
country: Spain
facility: Complejo Asistencial de León
Study officials:
affiliation: Complejo Asistencial de León
name: Alfonso Vidal-Casariego, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.7863/jum.2010.29.4.565.
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.
citation: Luo S, Kim EH, Dighe M, Kim Y. Screening of thyroid nodules by ultrasound elastography using diastolic strain variation. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:4420-3. doi: 10.1109/IEMBS.2009.5332744.
citation: Friedrich-Rust M, Sperber A, Holzer K, Diener J, Grunwald 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.
citation: Vidal-Casariego A, Lopez-Gonzalez L, Jimenez-Perez A, Ballesteros-Pomar MD, Kyriakos G, Urioste-Fondo A, Alvarez-San Martin R, Cano-Rodriguez I, Jimenez-Garcia de la Marina JM. Accuracy of ultrasound elastography in the diagnosis of thyroid cancer in a low-risk population. Exp Clin Endocrinol Diabetes. 2012 Nov;120(10):635-8. doi: 10.1055/s-0032-1323804. Epub 2012 Oct 16.