Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.

• Conditions: Thyroid Nodule
• Interventions: Diagnostic Test: ultrasound gray-scale ratio

• Registration Number: NCT03700762
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

According to the grades of echogenicity to evulated thyroid nodules is a subjective process and is thus influenced by the observer's judgement. The investigators first proposed the ultrasound gray-scale ratio (UGSR) to explore its efficacy for differentiating papillary thyroid microcarcinomas from small nodular goiters.

Detailed Description

Echogenicity is a common ultrasonic parameter to evaluate thyroid nodules. The echogenicity of the thyroid nodule was divided into 5 grades according to gray scale. Of the five categories, the diagnostic values of the hypoechoic and markedly hypoechoic categories have been widely accepted for thyroid malignant nodules. However, distinguishing between hypoechoic and markedly hypoechoic categories is a subjective process and is thus influenced by the observer's judgement. A more objective method should be proposed to differentiate papillary thyroid microcarcinoma(PTMC) from small nodular goiter(NG).

The investigators suspect the echo intensity of nodules could be reflected by values, as CT values reflecting the nodule density. The investigators first proposed the ultrasound gray-scale ratio (UGSR), namely, the ratio of lesion gray-scale value to surrounding normal thyroid tissue, and the previous study showed UGSR can better display the relationship of gray scale of PTMC or NG with surrounding normal thyroid tissue, and can make objective judgment of the nodules through quantitative results.

As the absolute ultrasound grayscale value is affected by the apparatus, scan gain, dynamic range, frequency, and operators. The investigators would collected different data acquired from different parameters to explore their potential relations.

Study Timeline

• Study First Submitted: 2018-07-07
• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted QC: 2018-10-06
• Last Update Submitted: 2018-10-06
• Study First Posted: 2018-10-09
• Last Update Posted: 2018-10-09
• Primary Completion: 2019-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

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

Inclusion Criteria

• patients diagnosed as thyroid nodule.
• homo-echogenicity of normal thyroid tissue.
• able and willing to comply with all study requirements.

Exclusion Criteria

• nodules are mainly cystic or calcified.
• pathology confirmed Hashimoto's thyroiditis.
• unable or unwilling to comply with all study requirements.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
evaluate by ultrasound gray-scale ratio	ultrasound gray-scale ratio	the results confirmed by the cut-off value of ultrasound gray-scale ratio

Primary Outcome Measures

Name	Time	Method
The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules.	All the data will be uploaded in 1 year.	The accuracy, sensitivity and specificity of UGSR in differentiating benign from malignant thyroid nodules.

Secondary Outcome Measures

Name	Time	Method
The best UGSR in differentiating benign from malignant thyroid nodules.	All the data will be uploaded in 1 year.	The cut-off value of UGSR in differentiating benign from malignant thyroid nodules.

Trial Locations

Locations (1)

The first people's hospital of Hangzhou; 🇨🇳 Hangzhou, Zhejiang, China