The Role of Elastography in the Diagnosis of Thyroid Nodules
|ClinicalTrials.gov Identifier: NCT01292044|
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : March 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Nodule Thyroid Neoplasms||Other: Elastography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||188 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of Elastography in the Diagnosis of Thyroid Nodules|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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.
A conventional thyroid echography performed before a the time of fine needle aspiration will include elastographic measurements for each node under study.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292044
|CHU de Nîmes - Hôpital Universitaire Carémeau|
|Nimes, Gard, France, 30029|
|Principal Investigator:||Véronique Taillard, MD||Centre Hospitalier Universitaire de Nîmes|
|Study Director:||Haitham Sharara, MD||Centre Hospitalier Universitaire de Nîmes|