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The Role of Elastography in the Diagnosis of Thyroid Nodules

18 Years
Open (Enrolling)
Thyroid Nodule, Thyroid Neoplasms

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Trial Information

The Role of Elastography in the Diagnosis of Thyroid Nodules

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.

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The difference between AUCs for the reference diagnostic method (cytology alone)and the new (cytology + elastography) diagnostic method.

Outcome Description:

Areas under the curves are estimated using the Wilcoxon-Mann-Chitney statistic. The gold standard is determined by anatomopathological examination of the excised tumor.

Outcome Time Frame:

15 days

Safety Issue:


Principal Investigator

Véronique Taillard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nîmes


France: Committee for the Protection of Personnes

Study ID:




Start Date:

November 2011

Completion Date:

December 2013

Related Keywords:

  • Thyroid Nodule
  • Thyroid Neoplasms
  • elastography
  • cytology
  • Neoplasms
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Thyroid Nodule