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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03700762
Enrollment
300
Registered
2018-10-09
Start date
2018-10-01
Completion date
2020-10-01
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

Keywords

Thyroid Nodule, differential diagnosis

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.

Interventions

DIAGNOSTIC_TESTultrasound 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.

Sponsors

First People's Hospital of Hangzhou
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Countries

China

Contacts

Primary ContactChenke Xu, Doctor
113614988@qq.com8613606503599

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026