Actively Recruiting

Age: 18Years +
All Genders
ID06146764

Contrast-enhanced Ultrasound Improves the Diagnostic Performance of Sonographic Risk Stratification System of Thyroid Carcinoma Comparing Integrated and Up-and-down Scoring Methods

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-03-23

800

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying thyroid nodules and thyroid carcinoma to evaluate two diagnostic scoring methods using contrast-enhanced ultrasound (CEUS) combined with gray-scale ultrasound. This trial aims to compare the integrated scoring method and the up-and-down scoring method for diagnosing thyroid nodules and determining the necessity of biopsy. This retrospective study follows accepted standards for diagnostic accuracy and includes participants who have undergone specific ultrasound tests and biopsies with confirmed benign or malignant results. Participants receive diagnostic evaluation involving conventional gray-scale ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy of thyroid nodules larger than 5 mm. The study includes a training set of 600 participants and an external validation set of 200 participants from different hospitals. The two scoring methods are used to assess the malignant risk of thyroid nodules and guide biopsy decisions. During the study, researchers collect ultrasound images and biopsy results to measure diagnostic performance and biopsy rates. They analyze how well each scoring method identifies malignant nodules and reduces unnecessary biopsies. Participant involvement includes undergoing the specified ultrasound procedures and biopsy, with data collected retrospectively. The study focuses on evaluating diagnostic accuracy and biopsy necessity, with results expected after the study's primary completion date.

CONDITIONS

Brief Title

CEUS Improves the Diagnostic Performance of SRSS of Thyroid Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 diagnosis
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 1 week

Participants undergo conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy to assess thyroid nodules.

1 to 2 visits depending on procedures

Long-term Monitoring

Duration - Up to primary completion date (until June 30, 2026)

Participants are observed following diagnostic procedures to evaluate diagnosis outcomes and unnecessary biopsy rates.

Follow-up as needed

Trial Site Locations

Total: 1 location

1

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

Guangzhou, Guangdong, China, 510289

Actively Recruiting

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Research Team

J

Jingliang Ruan, Ph.D.

X

Xiaming Ye, Master

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.

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The epidemiological landscape of thyroid cancer worldwide: GLOBOCAN estimates for incidence and mortality rates in 2020.

Margherita Pizzato, Mengmeng Li, Jerome Vignat...

https://pubmed.ncbi.nlm.nih.gov/35271818

2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer.

Bryan R Haugen, Erik K Alexander, Keith C Bible...

https://pubmed.ncbi.nlm.nih.gov/26462967

European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS.

Gilles Russ, Steen J Bonnema, Murat Faik Erdogan...

https://pubmed.ncbi.nlm.nih.gov/29167761

Ultrasonography Diagnosis and Imaging-Based Management of Thyroid Nodules: Revised Korean Society of Thyroid Radiology Consensus Statement and Recommendations.

Jung Hee Shin, Jung Hwan Baek, Jin Chung...

https://pubmed.ncbi.nlm.nih.gov/27134526

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ASSOCIAZIONE MEDICI ENDOCRINOLOGI MEDICAL GUIDELINES FOR CLINICAL PRACTICE FOR THE DIAGNOSIS AND MANAGEMENT OF THYROID NODULES--2016 UPDATE.

Hossein Gharib, Enrico Papini, Jeffrey R Garber...

https://pubmed.ncbi.nlm.nih.gov/27167915