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Elastography Interest in the Management of Thyroid Nodules (SWETHY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01335828
First received: November 10, 2010
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Thyroid Nodules
 Device: Medical ultrasound device (ShearWave system)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: "ShearWave" Elastography Interest in the Management of Thyroid Nodules

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Defined echo/elastography benignity criteria [ Time Frame: two and half years ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.

  • Assessing the use of elastography in clinical practice [ Time Frame: two and half years ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
echography/elastography Device: Medical ultrasound device (ShearWave system)
Echography (all modes) and elastography "ShearWave" system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335828

Locations
France
Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
Grenoble, France, 38043
Sponsors and Collaborators
AdministrateurCIC
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01335828     History of Changes
Other Study ID Numbers: DCIC 10 24
Study First Received: November 10, 2010
Last Updated: January 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Echography
Elastography
Thyroid nodules
 Needles punction
Thyroid surgery
Patients with thyroids nodules

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013