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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06029946
• Other study ID #: Elastography and DWI thyroid
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: salma ahmed ragheb, assistant lecturer
• Phone: 01025656052
• Email: salmarageb3456[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

Aghaghazvini L, Maheronnaghsh R, Soltani A, Rouzrokh P, Chavoshi M. Diagnostic value of shear wave sonoelastography in differentiation of benign from malignant thyroid nodules. Eur J Radiol. 2020 May;126:108926. doi: 10.1016/j.ejrad.2020.108926. Epub 2020 — View Citation

Cantisani V, David E, Grazhdani H, Rubini A, Radzina M, Dietrich CF, Durante C, Lamartina L, Grani G, Valeria A, Bosco D, Di Gioia C, Frattaroli FM, D'Andrea V, De Vito C, Fresilli D, D'Ambrosio F, Giacomelli L, Catalano C. Prospective Evaluation of Semiq — View Citation

Floridi C, Cellina M, Buccimazza G, Arrichiello A, Sacrini A, Arrigoni F, Pompili G, Barile A, Carrafiello G. Ultrasound imaging classifications of thyroid nodules for malignancy risk stratification and clinical management: state of the art. Gland Surg. 2 — View Citation

Gorgulu FF. Which Is the Best Reference Tissue for Strain Elastography in Predicting Malignancy in Thyroid Nodules, the Sternocleidomastoid Muscle or the Thyroid Parenchyma? J Ultrasound Med. 2019 Nov;38(11):3053-3064. doi: 10.1002/jum.15013. Epub 2019 Ap — View Citation

Kwak JY, Kim EK. Ultrasound elastography for thyroid nodules: recent advances. Ultrasonography. 2014 Apr;33(2):75-82. doi: 10.14366/usg.13025. Epub 2014 Feb 26. — View Citation

Qin P, Wu K, Hu Y, Zeng J, Chai X. Diagnosis of Benign and Malignant Thyroid Nodules Using Combined Conventional Ultrasound and Ultrasound Elasticity Imaging. IEEE J Biomed Health Inform. 2020 Apr;24(4):1028-1036. doi: 10.1109/JBHI.2019.2950994. Epub 2019 — View Citation

Swan KZ, Bonnema SJ, Jespersen ML, Nielsen VE. Reappraisal of shear wave elastography as a diagnostic tool for identifying thyroid carcinoma. Endocr Connect. 2019 Aug;8(8):1195-1205. doi: 10.1530/EC-19-0324. — View Citation

Wang H, Wei R, Liu W, Chen Y, Song B. Diagnostic efficacy of multiple MRI parameters in differentiating benign vs. malignant thyroid nodules. BMC Med Imaging. 2018 Dec 3;18(1):50. doi: 10.1186/s12880-018-0294-0. — View Citation

Wu Q, Li Y, Liu Y, Shen J, Wang Y, Yi X, Hu B. The value of conventional sonography and ultrasound elastography in decision-making for thyroid nodules in different categories of the Bethesda system for reporting thyroid cytopathology. Clin Hemorheol Micro — View Citation

Zhang WB, Li JJ, Chen XY, He BL, Shen RH, Liu H, Chen J, He XF. SWE combined with ACR TI-RADS categories for malignancy risk stratification of thyroid nodules with indeterminate FNA cytology. Clin Hemorheol Microcirc. 2020;76(3):381-390. doi: 10.3233/CH-2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Conventional ultrasound, color Doppler, TI-RADS, and shear wave elastography for thyroid nodule differentiation: a study of efficacy compared with the histopathology results
•   Diagnostic accuracy of B-mode ultrasound, ultrasound elastography and diffusion weighted MRI in differentiation of thyroid nodules (prospective study)
•   DIFFUSION WEIGHTED MAGNETIC RESONANCE IMAGING IN DIFFERENTIATION OF BENIGN AND MALIGNANT THYROID NODULES