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CompletedNCT01102127Updated May 25, 2011

Elastography in Thyroid Nodules

An observational study in Nodular Goiter and Thyroid Cancer, sponsored by Castilla-León Health Service. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-25.

Sponsored by Castilla-León Health Service · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
128
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Nodular Goiter
  • Thyroid Cancer

Keywords

  • elastography
  • thyroid nodule
  • fine-needle aspiration
03

In context

Goiter, Nodular

19 studies on the registry are indexed under Goiter, Nodular; 6 are open to participants now.

Browse Goiter, Nodular studies →

Lead sponsor

Castilla-León Health Service is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

General population with nodular goiter.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > 18 yr.
  • Recruitment in Endocrinology surgery.
  • Nodular goiter.
  • Multinodular goiter with dominant nodule > 1 cm.

Exclusion criteria

Exclusion Criteria:

  • Toxic nodules
  • Non-accessible nodules to US or FNA
  • Cystic nodules
  • Nodules with calcifications in egg rind
  • of FNA
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
128 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Goiter

    Patients with nodular goiter

    Device: Elastography

Interventions

  • DeviceElastography

    Performance of US, elastography and FNA.

06

What researchers measure

Primary outcomes

  1. Diagnostic accuracy of elastography for thyroid cancer

    Sensitivity, specifity, predictive values

    Time frame: 1 day

07

Study locations

1 site
  • Complejo Asistencial de León
    León, 24008, Spain
08

References and documents

Publications

  • 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. PubMed 20375375 ↗
  • 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. PubMed 20172470 ↗
  • 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. PubMed 19963828 ↗
  • 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. PubMed 19856256 ↗
  • 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. PubMed 23073921 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2010, a primary completion of Sep 2010 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2010
First posted
Apr 13, 2010
Start
Feb 2010
Primary completionActual
Sep 2010
CompletionActual
Sep 2010
Last update
May 25, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01102127
Lead sponsor
Castilla-León Health Service
First posted
Apr 13, 2010
Start date
Feb 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
May 25, 2011

Study contacts

Alfonso Vidal-Casariego, MD
principal investigator · Complejo Asistencial de León

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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