NCT06007859

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

August 17, 2023

Last Update Submit

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

Other: section orientation

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.

section orientation of ultrasound shear wave elastography

Eligibility Criteria

Age22 Years - 68 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

QianfoshanH

Shandong, China

Location

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

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.

Locations