Clinical trial NCT06029946: B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in Thyroid Nodules
Official title: Comparative Study of B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in the Characterization of Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thyroid Nodule
Keywords: Elastography
DWI thyroid
Thyroid Ultrasound
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study will include patients referred to the radiology department at Assuit university presented with clinically thyroid-related neck swelling

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)

Eligibility criteria: 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.

Primary outcomes:
measure: compare findings of ultrasound, elastography values , ADC value with the gold standard (biopsy results)
timeFrame: 1 year
Secondary outcomes:
measure: Apply ADC value Cut-off level to differentiate benign from malignant thyroid nodules
timeFrame: 1 year
measure: Apply US shear elastography parameters Cut-off levels to differentiate benign from malignant thyroid nodules.
timeFrame: 1 year
measure: Compare individual specific US features with the Gold standard US-guided FNAB which is more important.
timeFrame: 1 year
measure: Study role of color doppler in differentiating benign from malignant thyroid nodules
timeFrame: 1 year
measure: Compare the added value of combining different modalities, which have the higher sensitivity and specificity in differentiating benign from malignant thyroid nodules
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: nohamohamedali@yahoo.com
name: noha mohamed ali, assistant professor
role: STUDY_CHAIR
affiliation: samyKhalil24@gmail.com
name: sami Abdel_Aziz Khalil, professor
role: STUDY_DIRECTOR
References:
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 Nov 4.
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 Microcirc. 2020;74(3):255-266. doi: 10.3233/CH-180533.
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. 2019 Sep;8(Suppl 3):S233-S244. doi: 10.21037/gs.2019.07.01.
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-200893.
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.
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.
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.
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 Apr 29.
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 Semiquantitative Strain Ratio and Quantitative 2D Ultrasound Shear Wave Elastography (SWE) in Association with TIRADS Classification for Thyroid Nodule Characterization. Ultraschall Med. 2019 Aug;40(4):495-503. doi: 10.1055/a-0853-1821. Epub 2019 May 28.
citation: 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 Mar 3.