CEUS Improves the Diagnostic Performance of SRSS of Thyroid Carcinoma

NCT06146764 | Recruiting

• 1 other identifier: SYSKY-2023-1024-01
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Carcinoma; Thyroid Nodule

Keywords

Thyroid Nodule; Contrast Media; Gray-scale Ultrasound; Diagnosis; Biopsy

Outcome Measures

Primary Outcomes (2)

• Diagnostic performance

  Sensitivity, specificity, positive predictive value, negative predictive value, area under the curve

  First week after primary completion date

• Unnecessary biopsy rate

  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

Interventions

Contrast-enhanced Ultrasound DIAGNOSTIC_TEST

Integrated scoring method and up-and-down scoring method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510289, China

RECRUITING

Related Publications (16)

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MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms; Disease

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jingliang Ruan, Ph.D.

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

  PRINCIPAL INVESTIGATOR

• Baoming Luo, Professor

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

  STUDY DIRECTOR

Central Study Contacts

Jingliang Ruan, Ph.D.

CONTACT

+8613694202230; ruanjl3@mail.sysu.edu.cn

Xiaming Ye, Master

CONTACT

+8613660362226; Yexm7@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 27, 2023
• Study Start: March 18, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The first week after the publication of the research papers.
• Access Criteria: Data generated or analyzed during the study are available from the principal investigator by request.

Locations

CN (1)