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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01880203

Acronym

SWEETMAC

Enrollment

140

Registered

2013-06-18

Start date

2013-05-31

Completion date

2015-11-30

Last updated

2016-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indeterminate Cytology, Surgery Indication, Thyroid Node

Keywords

thyroid, elastography SWE, indeterminate cytology

Brief summary

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)

Interventions

PROCEDUREaspiration in thyroid node for Molecular Cytogenetic Analysis.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the diagnostic performance of the AMC and SWE elastography	at inclusion, before surgery	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.

Secondary

Measure	Time frame	Description
evaluate the diagnostic performance of elastography SWE	at inclusion, before surgery	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.
Establish a combined diagnostic score results of elastography	at inclusion, before surgery	Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026