Elastography in Thyroid Nodules

NCT ID: NCT01102127

Last Updated: 2011-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nodular Goiter Thyroid Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Goiter

Patients with nodular goiter

Elastography

Intervention Type DEVICE

Performance of US, elastography and FNA.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Elastography

Performance of US, elastography and FNA.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Castilla-León Health Service

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Complejo Asistencial de León

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alfonso Vidal-Casariego, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Asistencial de León

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Complejo Asistencial de León

León, León, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20375375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20172470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19963828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19856256 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23073921 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TNUS122009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.