Thyroid Nodule Clinical Trial
Official title:
Validation of the New Thyroid Imaging Reporting and Data System (TIRADS) From 2017 Risk Assessment of Thyroid Nodules in Comparison to the American Thyroid Association (ATA) Guidelines From 2015
Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on
high-resolution ultrasound .Ultrasound used in order to differentiate between benign and
malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US
guided ( Fine needle aspiration ) FNA is known to be the test of choice in order to determine
the nodules nature . Four to 6.5 % of all nodules are malignant .There are several guidelines
that were suggested to help predict the risk stratification of thyroid nodules by ultrasound
.
The American Thyroid Association (ATA) is widely used as evaluation, clinical and ultrasound
criteria for fine-needle aspiration biopsy and management of thyroid nodules. The recent ACR
TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American
College of Radiology (ACR) published april 2017 that uses a slightly different scoring system
for recommendation for FNA of thyroid.
The aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient
population in comparison to ATA risk stratification
Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on
high-resolution ultrasound .Ultrasound used in order to differentiate between benign and
malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US
guided ( Fine needle aspiration ) FNA is known to be the test of choice with sensitivity and
specificity were 89.5% and 98%, respectively in order to determine the nodules nature, . Four
to 6.5 % of all nodules are malignant .There are several guidelines that were suggested to
help predict the risk stratification of thyroid nodules by ultrasound .
The American Thyroid Association (ATA) guidelines which characterized the nodule by its size,
echogenicity, shape, presence or absence of calcification and evidence of Extrathyroidal
extension (ETE) is widely use as evaluation, clinical and ultrasound criteria for fine-needle
aspiration biopsy and management of thyroid nodules. These nodule characteristics classify
the risk for malignancy into five categories which include benign pattern, very low suspicion
pattern, low suspicion pattern, intermediate suspicious pattern and high suspicion pattern .
The recent ACR TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the
American College of Radiology (ACR) published april 2017 that uses a slightly different
scoring system for recommendation for FNA of thyroid nodules .The ultrasound features set by
TIRADS include composition, echogenicity, shape, margins and echogenic foci. The scoring
range according suspicion of malignancy.
The aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient
population in comparison to ATA risk stratification.
Methods
The study will be prospective Informed consent will be signed before the FNA All patients
referred for thyroid nodule FNA from outpatient and in patient clinics over 18 will be
included .
The nodule to undergo FNA will be chosen according to TIRADS ACR criteria and the ATA risk
criteria ( if there is a disagreement between the methods whether to perform FNA the FNA will
be performed ) If both methods do not recommend FNA , but the referring doctor has requested
the procedure or the patient is unable to stay on follow up , the FNA will be performed .
Data will be collected according the table Cytological results using Bethesda scoring and
surgery results, when applicable will be collected .
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04614389 -
Utility of Contrast-Enhanced Sonography and Shear Wave Elastography
|
N/A | |
| Recruiting |
NCT03295955 -
Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy
|
N/A | |
| Completed |
NCT04647006 -
Comparison of TOETVA and Conventional Thyroidectomy
|
N/A | |
| Not yet recruiting |
NCT06029946 -
B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in Thyroid Nodules
|
||
| Recruiting |
NCT05025046 -
NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
|
||
| Terminated |
NCT01320813 -
Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
|
N/A | |
| Completed |
NCT00877630 -
Minimal Invasiveness of Endoscopic Thyroidectomy
|
N/A | |
| Completed |
NCT01964508 -
microRNA in Thyroid Cancer
|
||
| Completed |
NCT06306599 -
Ultrasound Operator Influence on Diagnostics With AI for Thyroid Nodules - Clinial Trial
|
N/A | |
| Recruiting |
NCT04730726 -
In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules
|
N/A | |
| Not yet recruiting |
NCT03884140 -
Clinical Diagnostic Approach for Cases of Thyroid Nodules
|
||
| Completed |
NCT04277455 -
Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules
|
N/A | |
| Recruiting |
NCT02225509 -
Clinical Validation of a Molecular Signature to Detect Cancer in Thyroid Nodules With Indeterminate Cytology
|
N/A | |
| Completed |
NCT00552253 -
Levothyroxine Treatment in Thyroid Benign Nodular Goiter
|
N/A | |
| Not yet recruiting |
NCT03700762 -
Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
|
||
| Enrolling by invitation |
NCT01757834 -
Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
|
N/A | |
| Completed |
NCT01292044 -
The Role of Elastography in the Diagnosis of Thyroid Nodules
|
N/A | |
| Completed |
NCT00858104 -
Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results
|
Phase 4 | |
| Completed |
NCT00651625 -
Reciprocating Medical Devices - a Study of a New Safety Device
|
N/A | |
| Completed |
NCT05132478 -
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer
|
N/A |