Patients Who Underwent Thyroid Ultrasonography at Our Institution Were Selected for Shear Wave Elastography of Thyroid Nodules, and the Maximum and Mean Values of the Modulus of Elasticity of the Nodules in Transverse and Longitudinal Sections Were Analyzed.
SWE
Influence of Section Orientation of Ultrasound Shear Wave Elastography on the Measurement of Thyroid Nodules Stiffness
1 other identifier
observational
67
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedFirst Submitted
Initial submission to the registry
August 17, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedAugust 23, 2023
August 1, 2023
10 months
August 17, 2023
August 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
section orientation of ultrasound shear wave elastography
Interventions
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.
Eligibility Criteria
Patients with thyroid nodules attending the First Affiliated Hospital of Shandong First Medical University were selected.
You may qualify if:
- 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.
You may not qualify if:
- Unavailability of pathology results for various reasons; poor quality of ultrasound images; missing data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ma Zhelead
Study Sites (1)
QianfoshanH
Shandong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Ultrasound
Study Record Dates
First Submitted
August 17, 2023
First Posted
August 23, 2023
Study Start
February 1, 2022
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
August 23, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share
Lack of resources or infrastructure: Sharing IPDs requires resources and infrastructure to ensure data security, manage access requests and provide necessary documentation. Currently these resources are not well developed, so it may be difficult to share IPDs.