The Role of Elastography in the Diagnosis of Thyroid Nodules

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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: 187
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292044

Contacts
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

Locations
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         
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
  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 4, 2014
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 July 28, 2014