The Role of Elastography in the Diagnosis of Thyroid Nodules

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01292044
First received: February 8, 2011
Last updated: March 4, 2014
Last verified: March 2014

February 8, 2011
March 4, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
The difference between AUCs for the reference diagnostic method (cytology alone)and the new (cytology + elastography) diagnostic method. [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Areas under the curves are estimated using the Wilcoxon-Mann-Chitney statistic. The gold standard is determined by anatomopathological examination of the excised tumor.
Same as current
Complete list of historical versions of study NCT01292044 on ClinicalTrials.gov Archive Site
Not Provided
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The Role of Elastography in the Diagnosis of Thyroid Nodules
The Role of Elastography in the Diagnosis of Thyroid Nodules

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

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Thyroid Nodule
  • Thyroid Neoplasms
Other: Elastography
A conventional thyroid echography performed before a the time of fine needle aspiration will include elastographic measurements for each node under study.
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.
Intervention: Other: Elastography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
187
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Véronique M Taillard, MD +33.(0)4.66.68.32.51 verotaillard@9online.fr
Contact: Carey M Suehs 3466686788 carey.suehs@chu-nimes.fr
France
 
NCT01292044
AOI/2010/VT-02, 2010-AO1276-33
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Véronique Taillard, MD Centre Hospitalier Universitaire de Nîmes
Study Director: Haitham Sharara, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP