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

NCT06029946 | Unknown

• 1 other identifier: Elastography and DWI thyroid
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroid Nodule

Keywords

Elastography; DWI thyroid; Thyroid Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Apply ADC value Cut-off level to differentiate benign from malignant thyroid nodules

  1 year

• Apply US shear elastography parameters Cut-off levels to differentiate benign from malignant thyroid nodules.

  1 year

• Compare individual specific US features with the Gold standard US-guided FNAB which is more important.

  1 year

• Study role of color doppler in differentiating benign from malignant thyroid nodules

  1 year

• Compare the added value of combining different modalities, which have the higher sensitivity and specificity in differentiating benign from malignant thyroid nodules

  1 year

Interventions

elastography, ultrasound DIAGNOSTIC_TEST

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.

Also known as: MRI and fine needle biopsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• 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.

  PMID: 31689223 RESULT

• 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.

  PMID: 31683465 RESULT

• 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.

  PMID: 31559190 RESULT

• 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.

  PMID: 32675401 RESULT

• 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.

  PMID: 31340198 RESULT

• 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.

  PMID: 24936499 RESULT

• 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.

  PMID: 30509198 RESULT

• 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.

  PMID: 31037753 RESULT

• 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.

  PMID: 31137050 RESULT

• 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.

  PMID: 32171916 RESULT

Related 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

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Elasticity Imaging Techniques; Ultrasonography; Magnetic Resonance Imaging; Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• noha mohamed ali, assistant professor

  nohamohamedali@yahoo.com

  STUDY CHAIR

• sami Abdel_Aziz Khalil, professor

  samyKhalil24@gmail.com

  STUDY DIRECTOR

Central Study Contacts

salma ahmed ragheb, assistant lecturer

CONTACT

01025656052; salmarageb3456@gmail.com

Mona Gouda Maghrabi, lecturer

CONTACT

01062307637; Mona.gouda@medicine.luxor.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer, Luxor university

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: September 8, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09