CEUS Improves the Diagnostic Performance of SRSS of Thyroid Carcinoma

November 27, 2023 updated by: Jingliang Ruan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Contrast-enhanced Ultrasound Improves the Diagnostic Performance of Sonographic Risk Stratification System of Thyroid Carcinoma: Comparison Between Integrated Scoring Method and Up-and-down Scoring Method

Contrast-enhanced ultrasound (CEUS) can sensitively show the blood perfusion characteristics of thyroid nodules, which is a useful supplement to gray-scale ultrasound. However, there is no standard combined diagnostic method of gray-scale ultrasound and CEUS. Therefore, the aim of this study was to compare the diagnostic performance of the integrated scoring method and the up-and-down scoring method. This study was a multicenter retrospective clinical study and followed the Standards for Reporting of Diagnostic Accuracy Studies (version 2015). Inclusion criteria: 1) participants with at least one thyroid nodule larger than 5 mm confirmed by conventional ultrasound; 2) participants underwent gray-scale ultrasound, contrast-enhanced ultrasound and fine needle aspiration biopsy of the thyroid nodule successively; 3) participants have a final diagnosis of benign or malignant. Exclusion criteria included: 1) participants with cytologic findings of Bethesda I, III, or IV without definitive benign or malignant pathologic findings; 2) participants with a history of thyroid fine needle aspiration, ablation or surgery; 3) participants with low quality ultrasound images (e.g., severe artifacts or low image resolution). According to the American College of Radiology Thyroid Imaging Reporting and Data System, only one thyroid nodule with the highest point was included in each participant. A total of 600 participants from January 2018 to December 2022 were consecutively included in Sun Yat-sen Memorial Hospital of Sun Yat-sen University to form a training set (average age 48 years; Range 24-81 years old). A total of 200 subjects with thyroid nodules from January 2022 to December 2022 were consecutively included to form an external validation set in Houjie Hospital of Dongguan City, Guangdong Province (mean age 46 years; Range 30-74 years). The malignant risk of enrolled thyroid nodules and the necessity of biopsy were evaluated by integrated scoring method and up-and-down scoring method, respectively. The diagnostic performance and unnecessary biopsy rate of the above two methods were calculated and compared.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510289
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

We included patients at Sun Yat-sen Memorial Hospital (the internal validation set) and Houjie Hospital of Dongguan(the external validation set) at the same eligibility criteria described above from January 2021 to December 2022.

Description

Inclusion Criteria:

  • Participants with thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound;
  • Participants who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy;
  • Participants with a final benign or malignant pathological results.

Exclusion Criteria:

  • Participants with cytopathology of Bethesda I, III, or IV and without final benign or malignant pathology；
  • Participants with a history of thyroid ablation or surgery;
  • Participants with low-quality ultrasound images.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance
Time Frame: First week after primary completion date
Sensitivity, specificity, positive predictive value, negative predictive value, area under the curve
First week after primary completion date
Unnecessary biopsy rate
Time Frame: First week after primary completion date
The unnecessary biopsy rate was defined as a percentage of the number of benign nodules among biopsy-indicated nodules in the total nodules.
First week after primary completion date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Jingliang Ruan, PhD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Study Director: Baoming Luo, Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

November 18, 2023

First Submitted That Met QC Criteria

November 24, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2023-1024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data generated or analyzed during the study are available from the principal investigator by request.

IPD Sharing Time Frame

The first week after the publication of the research papers.

IPD Sharing Access Criteria

Data generated or analyzed during the study are available from the principal investigator by request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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