"ShearWave" Elastography Interest in the Management of Thyroid Nodules
Phase 2/Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Thyroid Nodules
Both
Thyroid Nodules
Trial Information
"ShearWave" Elastography Interest in the Management of Thyroid Nodules
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Defined echo/elastography benignity criteria
Outcome 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
Outcome Time Frame:
two and half years
Safety Issue:
Yes
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
DCIC 10 24
NCT ID:
NCT01335828
Start Date:
November 2010
Completion Date:
November 2012
Related Keywords:
- Thyroid Nodules
- Echography
- Elastography
- Thyroid nodules
- Needles punction
- Thyroid surgery
- Patients with thyroids nodules
- Thyroid Diseases
- Thyroid Nodule
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