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The Role of Elastography in the Diagnosis of Thyroid Nodules

This study has been completed.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes Identifier:
First received: February 8, 2011
Last updated: March 26, 2015
Last verified: March 2015
The primary objective of this study is to evaluate the role of elastography (along with echographic and cytological data) as a diagnostic tool for thyroid cancer

Condition Intervention
Thyroid Nodule Thyroid Neoplasms Other: Elastography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Elastography in the Diagnosis of Thyroid Nodules

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • The difference between AUCs for the reference diagnostic method (cytology alone)and the new (cytology + elastography) diagnostic method. [ Time Frame: 15 days ]
    Areas under the curves are estimated using the Wilcoxon-Mann-Chitney statistic. The gold standard is determined by anatomopathological examination of the excised tumor.

Enrollment: 188
Study Start Date: November 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The study population
The study population consists of patients for whom an echo-guided fine-needle aspiration was performed for one or more thyroid nodes, and for whom surgical node excision is required.
Other: Elastography
A conventional thyroid echography performed before a the time of fine needle aspiration will include elastographic measurements for each node under study.

Detailed Description:

Ultrasound is considered the first line examination in the exploration of the thyroid nodule. Echotexture analysis often identifies nodules at risk of malignancy, but does not replace or exclude an additional cytological exploration. Cytology, although effective, also has limitations, particularly when samples are vesicular and it is difficult discern between a benign or malignant state. The creation of a noninvasive method in this context could help to avoid invasive tests or "useless" surgical procedures.

Ultrasound elastography, which assesses tissue deformability, may provide valuable information concerning benign soft tissue characteristics, whereas malignant lesions are harder in consistency. Interest in this method, already proposed for other organs, has recently increased due to the emergence of specifically created software that enables objective evaluation of the hardness of the nodule during a conventional ultrasound analysis. The main hypothesis of this study is that elastography should allow better selection of candidates for thyroid surgery.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for six months of follow-up
  • The patient is programmed for surgical excision of all nodules determined to be not benign according to cytological criteria

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant
  • The patient is breastfeeding
  • The patient has a contraindication for a treatment used in this study
  • The patient has a contraindication for surgical excision of his/her thyroid nodule
  • The patient refused to be operated
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Please refer to this study by its identifier: NCT01292044

CHU de Nîmes - Hôpital Universitaire Carémeau
Nimes, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Principal Investigator: Véronique Taillard, MD Centre Hospitalier Universitaire de Nîmes
Study Director: Haitham Sharara, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes Identifier: NCT01292044     History of Changes
Other Study ID Numbers: AOI/2010/VT-02
2010-AO1276-33 ( Other Identifier: RCB number )
Study First Received: February 8, 2011
Last Updated: March 26, 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms processed this record on September 18, 2017