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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06007859
Other study ID # YXLL-KY-2023(024)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date November 30, 2022

Study information

Verified date August 2023
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this observational study was to evaluate the effect of transverse and longitudinal sections on the measurement of thyroid nodule stiffness by shear wave elastography. The main questions it aims to answer are: (i) to compare the diagnostic efficacy of different section orientations of shear wave elastography for the diagnosis of benign and malignant thyroid nodules; (ii) to analyze the correlation between the two orientations of transverse and longitudinal sections of shear wave elastography; and (iii) to compare the reliability and consistency of the two orientations of transverse and longitudinal sections of shear wave elastography for the diagnosis of thyroid nodules. Participants will undergo routine ultrasound examination of the thyroid gland and shear wave elastography, and the measured modulus of elasticity of the nodules in both transverse and longitudinal sections will be recorded.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers
Gender All
Age group 22 Years to 68 Years
Eligibility Inclusion Criteria: All patients underwent preoperative shear-wave elastography ultrasonography; thyroid nodules ranged from 3 to 20 mm in size; all nodules underwent puncture biopsy or surgery to obtain pathologic results. Exclusion Criteria: Unavailability of pathology results for various reasons; poor quality of ultrasound images; missing data.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
section orientation
The patient was placed in a decubitus supine head back extension position to fully expose the cervical thyroid examination site. The instrument was adjusted appropriately to achieve optimal imaging quality, the suspicious nodule was located in conventional ultrasound mode, the SWE option in VT mode was selected, and the patient was instructed to hold his/her breath to minimize the effect of respiration, and elastograms of the nodule in transverse and longitudinal sections were obtained.

Locations

Country Name City State
China QianfoshanH Shandong

Sponsors (1)

Lead Sponsor Collaborator
Ma Zhe

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary elastic modulus values the maximum value of elastic modulus (Emax) and the average value of elastic modulus (Emean) of benign and malignant nodules in both longitudinal and transverse sections The elastic modulus values of different sections were recorded immediately after the patients underwent routine ultrasound and shear wave elastography and the recorded results were saved.
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