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Trial Title:
CEUS Improves the Diagnostic Performance of SRSS of Thyroid Carcinoma
NCT ID:
NCT06146764
Condition:
Thyroid Nodule
Thyroid Carcinoma
Conditions: Official terms:
Carcinoma
Thyroid Nodule
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
Thyroid Nodule
Contrast Media
Gray-scale Ultrasound
Diagnosis
Biopsy
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Contrast-enhanced Ultrasound
Description:
Integrated scoring method and up-and-down scoring method
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510289
Country:
China
Start date:
January 1, 2024
Completion date:
April 15, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06146764
