The Role of Elastography in the Diagnosis of Thyroid Nodules

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT01292044

Collaborator

(none)

188

Enrollment

Location

Arm

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Thyroid Nodule Thyroid Neoplasms	Other: Elastography	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

188 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

The Role of Elastography in the Diagnosis of Thyroid Nodules

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nîmes - Hôpital Universitaire Carémeau	Nimes	Gard	France	30029

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Véronique Taillard, MD, Centre Hospitalier Universitaire de Nîmes
Study Director: Haitham Sharara, MD, Centre Hospitalier Universitaire de Nîmes