Clinical trial NCT03700762: Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
Official title: Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Nodule
Keywords: Thyroid Nodule
differential diagnosis
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with thyroid nodules by ultrasound or incidentally noted on other imaging tests.

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.

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.

Primary outcomes:
measure: The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules.
timeFrame: All the data will be uploaded in 1 year.
Secondary outcomes:
measure: The best UGSR in differentiating benign from malignant thyroid nodules.
timeFrame: All the data will be uploaded in 1 year.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first people's hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
name: Zhijiang Han, Doctor
role: STUDY_DIRECTOR
References: