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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03700762
• Other study ID #: 2018-108-01
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2018
• Source: First People's Hospital of Hangzhou
• Contact: Chenke Xu, Doctor
• Phone: 8613606503599
• Email: 113614988[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Diagnostic Test:
• ultrasound gray-scale ratio
RADinfo radiograph reading system was used to measure the gray-scales of PTMC, NG, and thyroid tissues at the same gain level, the UGSR values of the PTMC, NG, and thyroid tissue were calculated.

Locations

Country	Name	City	State
China	The first people's hospital of Hangzhou	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules.	The accuracy, sensitivity and specificity of UGSR in differentiating benign from malignant thyroid nodules.	All the data will be uploaded in 1 year.
Secondary	The best UGSR in differentiating benign from malignant thyroid nodules.	The cut-off value of UGSR in differentiating benign from malignant thyroid nodules.	All the data will be uploaded in 1 year.