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

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.

Study Overview

• Status: Unknown
• Conditions: Thyroid Nodule
• Intervention / Treatment: Diagnostic test: ultrasound gray-scale ratio

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The First People's Hospital of Hangzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with thyroid nodules by ultrasound or incidentally noted on other imaging tests.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pathologically results; finally proved by pathologically results
evaluate by ultrasound gray-scale ratio; the results confirmed by the cut-off value of ultrasound gray-scale ratio	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou
• Investigators: Study Director: Zhijiang Han, Doctor, The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: July 7, 2018
• First Submitted That Met QC Criteria: October 6, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 6, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: differential diagnosis; Thyroid Nodule
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: 2018-108-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No