Thyroid Disease Diagnosis by Mutiple Ultrasonic Factors.

• Conditions: Diagnoses Disease; Thyroid; Nodule

• Registration Number: NCT04388956
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.

Detailed Description

4 to 7 percent of adult population has a palpable thyroid nodule and 17% to 27% of cases can be found when examined by sonography. Although the incidence of the thyroid nodules is high, only 1 of 20 clinically identified nodules is malignant.

Several gray scale sonographic characteristics have been suggestive of malignancy, including hypoechoigenicity, micro calcification, blurred margin and intranodular vascularity. The intranodular vascularity has been studied in several researches. But the previous studies usually evaluated the vascularity by color Doppler sonography and only divided into several categories subjectively. And the result is controversial.

The evaluation of the tumor microcirculation by Doppler ultrasound has been used in many tumors and defined as vascularity index (VI). The power Doppler sonography has many advantages over color Doppler ultrasound in studying the vascularity. It is more sensitive, less noisy. Power Doppler can detect the blood flow of small internal tumor vessels with a diameter of less than 100μm at slow flow rates on the order of a few mm per second1,2 According to our previous study, the vascularity index(PDVI) of thyroid tumor by power Doppler ultrasound between benign and malignant one are statistically different.

In the present study, the investigators examine different PDVI of thyroid tumors and the traditional（B-mode）ultrasound features including the heterogeneity, echogenicity, margin status, and the presence of microcalcification. The investigators consider the several factors simultaneously by statistical model (PCA, FLD). In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-09
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• patients who have discrete solid thyroid tumors need to undergo fine-needle aspiration cytology to provide the tentative diagnosis
• discrete thyroid tumors with mainly solid content (>50% solid content) and diameter of tumors between 0.5-3cm

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Exclusion Criteria

• abnormal thyroid function, past history of thyroiditis, multinodular goiter, and cystic tumors.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ultrasound evaluation	3 days	Patients who were eligible for this trial will receive the new model of ultrasound evaluation . The traditional features including echogenicity, margin, heterogeneity, size and the presence of microcalcification will be recorded in the same time. Then the investigators evaluate the thyroid tumor vascularity in sagittal and transverse section by power Doppler mode (wall filter (WF): medium, colour power angiography (CPA): 82, retroperitoneal fibrosis (RPF): 1000). The DICOM data of the vascularity index(PDVI) will be collected and analyzed later.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan