Elastography Interest in the Management of Thyroid Nodules

Phase 2

Completed

• Conditions: Thyroid Nodules
• Interventions: Device: Medical ultrasound device (ShearWave system)

• Registration Number: NCT01335828
• Lead Sponsor: AdministrateurCIC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
echography/elastography	Medical ultrasound device (ShearWave system)	-

Primary Outcome Measures

Name	Time	Method
Defined echo/elastography benignity criteria	two and half years	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

Secondary Outcome Measures

Name	Time	Method
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	two and half years	ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.
Assessing the use of elastography in clinical practice	two and half years

Trial Locations

Locations (1)

Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France; 🇫🇷 Grenoble, France