CEUS Improves the Diagnostic Performance of SRSS of Thyroid Carcinoma

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06146764

Collaborator

(none)

800

Enrollment

Location

3.4

Anticipated Duration (Months)

231.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodule Thyroid Carcinoma	Diagnostic Test: Contrast-enhanced Ultrasound

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Apr 15, 2024

Outcome Measures

Primary Outcome Measures

Diagnostic performance [First week after primary completion date]
Sensitivity, specificity, positive predictive value, negative predictive value, area under the curve
Unnecessary biopsy rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510289

Sponsors and Collaborators

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