The Role of Elastography in the Diagnosis of Thyroid Nodules
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Purpose
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: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Role of Elastography in the Diagnosis of Thyroid Nodules |
- 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.
| Estimated Enrollment: | 140 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Recruiting |
| Nimes, Gard, France, 30029 | |
| Principal Investigator: Taillard M Véronique, MD | |
| Sub-Investigator: Sharara M Haitham | |
| Sub-Investigator: Rodier M Michel | |
| Sub-Investigator: Heliette Chapuis, MD | |
| Sub-Investigator: Benjamin lallemant, MD | |
| Sub-Investigator: Guillaume Chambon, MD | |
| Principal Investigator: | Véronique Taillard, MD | Centre Hospitalier Universitaire de Nîmes |
| Study Director: | Haitham Sharara, MD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01292044 History of Changes |
| Other Study ID Numbers: | AOI/2010/VT-02, 2010-AO1276-33 |
| Study First Received: | February 8, 2011 |
| Last Updated: | March 22, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
elastography cytology |
Additional relevant MeSH terms:
|
Neoplasms Thyroid Neoplasms Thyroid Diseases Thyroid Nodule |
Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013