Elastography Interest in the Management of Thyroid Nodules

Thyroid Nodules Clinical Trial

— SWETHY  

Official title:

"ShearWave" Elastography Interest in the Management of Thyroid Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335828
• Other study ID #: DCIC 10 24
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 10, 2010
• Last updated: January 24, 2013
• Start date: November 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged over 18 years old

• Patient affiliated to social security or similarly regime

• Patients referred for fine needle aspiration or surgery with one or more thyroid nodules

Exclusion Criteria:

• Patients with too much thyroid nodules or topography too imprecise to allow unambiguous correlation between echo/elastography data and histology/cytology data

• Patients withan echography/elastography indications cons

• Pregnant women and lactating mothers

• Adult unable to express their consent

• Ward of court or under guardianship

• Person under legal protection

• Person deprived of freedom by judicial or administrative decision

• Person hospitalized without their consent

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule
• Thyroid Nodules

Intervention

Device:
• Medical ultrasound device (ShearWave system)
Echography (all modes) and elastography "ShearWave" system

Locations

Country	Name	City	State
France	Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
AdministrateurCIC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defined echo/elastography benignity criteria	For ultrasound and elastography benignity criteria which will be retained, outcome focus on cytoponctions number for benin nodules can be avoided by taking into account this benign criteria	two and half years
Secondary	Evaluate the diagnostic performance of elastography ShearWave for characterization of thyroid nodules in a population of patients referred for needle biopsy or surgery nodule thyroid	ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.	two and half years
Secondary	Assessing the use of elastography in clinical practice		two and half years