Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study

Study Overview
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Brief Summary
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The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)

Official Title
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Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study

Conditions
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Thyroid Node, Indeterminate Cytology, Surgery Indication

Intervention / Treatment
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* Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients with thyroid nodules ≥ 15 mm with an indeterminate cytology (IC) older than 6 months, for which a surgical indication was raised vesicular lesion of undetermined significance follicular neoplasm or Hurthle cells lesion suspicious for malignancy Confirmation of indeterminate cytology (IC) replay centralized Patient affiliated to a social security scheme Informed consent and signed Exclusion Criteria: Thyroid node <15 mm Nodules coalescing preventing proper individualization of targeted nodule Indeterminate cytology older than six months Nodules with indeterminate cytology not, ie non-diagnostic cytology, benign and malignant cytology cytology Major subject to a measure of legal protection or unable to consent Refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspiration for Molecular Cytogenetic Analysis.<br> | Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis.<br> <br> * Other names: cervical ultrasound with elastography SWE followed by a new ultrasound-guided fine needle aspiration for Molecular Cytogenetic Analysis.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the diagnostic performance of the AMC and SWE elastography | Evaluate the diagnostic performance of the AMC and SWE elastography in patients with a thyroid nodule CI taking as reference the histology of the nodule. | at inclusion, before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the diagnostic performance of elastography SWE | For elastography SWE validate decision thresholds for the parameters of elasticity of thyroid nodules, and evaluate the diagnostic performance of elastography SWE combined with those of the standard ultrasound. | at inclusion, before surgery | 
| Establish a combined diagnostic score results of elastography | Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis | at inclusion, before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid, elastography SWE, indeterminate cytology