Back to resultsElastography Interest in the Management of Thyroid Nodules (SWETHY)
Primary Purpose
Thyroid Nodules
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Medical ultrasound device (ShearWave system)
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Nodules focused on measuring Echography, Elastography, Thyroid nodules, Needles punction, Thyroid surgery, Patients with thyroids nodules
Eligibility 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
Sites / Locations
- Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
echography/elastography
Arm Description
Outcomes
Primary Outcome Measures
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
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
ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.
Assessing the use of elastography in clinical practice
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01335828
Brief Title
Elastography Interest in the Management of Thyroid Nodules
Acronym
SWETHY
Official Title
"ShearWave" Elastography Interest in the Management of Thyroid Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
AdministrateurCIC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodules
Keywords
Echography, Elastography, Thyroid nodules, Needles punction, Thyroid surgery, Patients with thyroids nodules
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
echography/elastography
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Medical ultrasound device (ShearWave system)
Intervention Description
Echography (all modes) and elastography "ShearWave" system
Primary Outcome Measure Information:
Title
Defined echo/elastography benignity criteria
Description
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
Time Frame
two and half years
Secondary Outcome Measure Information:
Title
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
Description
ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.
Time Frame
two and half years
Title
Assessing the use of elastography in clinical practice
Time Frame
two and half years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Learn more about this trial
Elastography Interest in the Management of Thyroid Nodules
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