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

NCT ID: NCT03700762

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-10-01

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.

Conditions

Thyroid Nodule

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

pathologically results

finally proved by pathologically results

No interventions assigned to this group

evaluate by ultrasound gray-scale ratio

the results confirmed by the cut-off value of ultrasound gray-scale ratio

ultrasound gray-scale ratio

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhijiang Han, Doctor

Role: STUDY_DIRECTOR

The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Locations

The first people's hospital of Hangzhou

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Chenke Xu, Doctor

Role: CONTACT

113614988@qq.com

8613606503599

Facility Contacts

Chenke Xu, Doctor

Role: primary

113614988@qq.com

8613606503599

Other Identifiers

2018-108-01

Identifier Type: -

Identifier Source: org_study_id