B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in Thyroid Nodules

Study Overview
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Brief Summary
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To compare the accuracy of the conventional Ultrasound 'TI-RADS', US elastography, DWI MRI, and its ADC value in characterization and differentiation of thyroid nodules.

Detailed Description
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Thyroid nodules are one of the most common endocrine carcinomata (1) Most thyroid tumors have a good prognosis if early diagnosis and timely treated (2) An Ultrasound (US) exam is a safe, non-invasive imaging technique for detecting thyroid nodules (3) However, still there are no dependable criteria to discriminate malignant from benign lesions. (4) In 2009, Horvath et al proposed the Thyroid Imaging Report and Data System (TI-RADS). The new version of TI-RADS was launched by ACR in 2017. (5) Color Doppler ultrasound is also used to differentiate benign from malignant thyroid nodules. The presence of intra-nodular vascularity (Type 1b) was considered close to be malignant (6) US elastography is a novel tool to increase the diagnostic value of Ultrasound and as an adjuvant tool (7) Shear wave elastography evaluates elasticity through the propagation speed of shear waves, with the wave speed being faster in hard tissue (8) Conventional T1-and T2-weighted MR imaging can-not differentiate benign from malignant nodules (9) Diffusion-weighted imaging (DWI) is a non-invasive tool used to distinguish benign from malignant nodules (10). Malignant thyroid nodules usually have a lower ADC value attributed to cellular density and tissue perfusion. (11) Combining subjective MRI features with a quantitative measurement could improve the diagnostic yield of DW-MRI (12) The cytological examination by fine-needle aspiration (FNA) has become a reliable tool to diagnose thyroid cancers (2) Suspicious cytological findings reach up to 30% of all aspirated nodules, suggesting the need for less invasive methods (13)

Official Title
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Comparative Study of B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in the Characterization of Thyroid Nodules

Conditions
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Thyroid Nodule

Intervention / Treatment
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* Diagnostic Test: elastography, ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should have a normal bleeding profile. Presence of solitary or multiple nodules in the thyroid gland. In the case of patients having multiple nodules, the nodule having suspicious ultrasound features (having TI-RADS score 4 or 5) was selected for further analysis. The nodules were either solid or mixed (containing both solid and cystic parts) with a predominant solid component Exclusion Criteria: Contraindicated biopsy (as thrombocytopenia or bleeding disorder). Patient with cystic and mainly cystic nodules (TI-RADS 1 nodules). Nodules with complete shell-calcification which may cause color mapping artifacts. MRI contraindications such as Claustrophobia, MR-incompatible pacemakers, and MR-incompatible prosthetic heart valves. Patients with recurrent thyroid masses. History of operative procedure, chemo, or radiotherapy on the thyroid gland. Declined consent.
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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: elastography, ultrasound|First local anesthesia with lidocaine 2%, then 3 smears will be obtained for each nodule using a 20-22 gauge needle, multiple passes within the lesion will be made to obtain sufficient cells, the aspirate will be spread over a glass, fixed with ethanol 95% and submitted to the pathology department to be reported.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare findings of ultrasound, elastography values , ADC value with the gold standard (biopsy results) | To assess concordance of US suspicious features, US elastography results , MRI DWI, ADC value results, and the gold standard US-guided FNAB and ability to differentiate benign from malignant thyroid nodules. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apply ADC value Cut-off level to differentiate benign from malignant thyroid nodules | compare ADC value of benign and malignant nodules to obtain a cutoff level | 1 year | 
| Apply US shear elastography parameters Cut-off levels to differentiate benign from malignant thyroid nodules. | compare also benign and malignant nodules qualitative and quantitative elastography results. qualitative measurement is defined as :each nodule was assigned an elasticity score based on the color pattern type according to the classification proposed by Ueno classification method (color coded map) ranging from blue to green colors. hard nodules on the map appears as blue color and soft nodules appears as red color. Quantitative assessment of the velocity of US wave propagation through tissue. measurement units are: kilopascal (Kpa), and shear wave velocity (m/sec). | 1 year | 
| Compare individual specific US features with the Gold standard US-guided FNAB which is more important. | which is the most suspicious feature in ulrasound. The five Ultrasound suspicious features are: predominantly Solid nodule. Marked hypoechogenicity. Microlobulated or irregular margins. Micro-Calcifications. Taller-than-wide in shape with a ratio ≥ 1. | 1 year | 
| Study role of color doppler in differentiating benign from malignant thyroid nodules | which pattern of color doppler study is the most suspicious: Classified into 4 groups: 0= Avascular. 1a= Peri-nodular vascularity. 1b= Intra-nodular vascularity. 1c= Peri-nodular and intranodular vascularity. | 1 year | 
| Compare the added value of combining different modalities, which have the higher sensitivity and specificity in differentiating benign from malignant thyroid nodules | combination of different imaging modalities which will have the best sensitivity and specificity for diagnosis of malignant thyroid nodules | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elastography, DWI thyroid, Thyroid Ultrasound