Clinical trial · Observational

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

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

NCT06029946CI-TRIAL-00069440unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Thyroid Nodule	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
elastography, ultrasound	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

[]

Primary outcomes (1)

measure
compare findings of ultrasound, elastography values , ADC value with the gold standard (biopsy results)
timeFrame
1 year
description
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 outcomes (5)

measure
Apply ADC value Cut-off level to differentiate benign from malignant thyroid nodules
timeFrame
1 year
description
compare ADC value of benign and malignant nodules to obtain a cutoff level
measure
Apply US shear elastography parameters Cut-off levels to differentiate benign from malignant thyroid nodules.
timeFrame
1 year
description

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

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.

References

Publications (10)

RESULTQin 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
RESULTWu 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
RESULTFloridi 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
RESULTZhang 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
RESULTSwan 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
RESULTKwak 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
RESULTWang 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.