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Completed

NCT Number: NCT01335828

Elastography Interest in the Management of Thyroid Nodules

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

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Key information

Conditions

Thyroid Nodules Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical ultrasound device (ShearWave system)

Device

Echography (all modes) and elastography "ShearWave" system

Primary outcomes

  1. Defined echo/elastography benignity criteria

    Time frame: 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 outcomes

  1. 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

    Time frame: two and half years

    ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.

  2. Assessing the use of elastography in clinical practice

    Time frame: two and half years

Sponsors and collaborators

Lead sponsor

AdministrateurCIC

Other

Registry information

Official study title

"ShearWave" Elastography Interest in the Management of Thyroid Nodules

Acronym: SWETHY

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 14, 2011
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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