B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in Thyroid Nodules
- Conditions
- Thyroid Nodule
- Registration Number
- NCT06029946
- Lead Sponsor
- Assiut University
- Brief Summary
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
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)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method compare findings of ultrasound, elastography values , ADC value with the gold standard (biopsy results) 1 year 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.
- Secondary Outcome Measures
Name Time Method Study role of color doppler in differentiating benign from malignant thyroid nodules 1 year 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.Apply ADC value Cut-off level to differentiate benign from malignant thyroid nodules 1 year compare ADC value of benign and malignant nodules to obtain a cutoff level
Apply US shear elastography parameters Cut-off levels to differentiate benign from malignant thyroid nodules. 1 year 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).Compare individual specific US features with the Gold standard US-guided FNAB which is more important. 1 year which is the most suspicious feature in ulrasound.
The five Ultrasound suspicious features are:
1. predominantly Solid nodule.
2. Marked hypoechogenicity.
3. Microlobulated or irregular margins.
4. Micro-Calcifications.
5. Taller-than-wide in shape with a ratio ≥ 1.Compare the added value of combining different modalities, which have the higher sensitivity and specificity in differentiating benign from malignant thyroid nodules 1 year combination of different imaging modalities which will have the best sensitivity and specificity for diagnosis of malignant thyroid nodules