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Elastography Interest in the Management of Thyroid Nodules

ShearWave Elastography Interest in the Management of Thyroid Nodules

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01335828
Acronym
SWETHY
Enrollment
125
Registered
2011-04-14
Start date
2010-11-30
Completion date
2012-11-30
Last updated
2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodules

Keywords

Echography, Elastography, Thyroid nodules, Needles punction, Thyroid surgery, Patients with thyroids nodules

Brief summary

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

Interventions

DEVICEMedical ultrasound device (ShearWave system)

Echography (all modes) and elastography ShearWave system

Sponsors

AdministrateurCIC
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Defined echo/elastography benignity criteriatwo and half yearsFor 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

MeasureTime frameDescription
Evaluate the diagnostic performance of elastography ShearWave for characterization of thyroid nodules in a population of patients referred for needle biopsy or surgery nodule thyroidtwo and half yearsROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.
Assessing the use of elastography in clinical practicetwo and half years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026