Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
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|ClinicalTrials.gov Identifier: NCT03700762|
Recruitment Status : Unknown
Verified October 2018 by First People's Hospital of Hangzhou.
Recruitment status was: Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment|
|Thyroid Nodule||Diagnostic Test: ultrasound gray-scale ratio|
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|
|Estimated Enrollment :||300 participants|
|Official Title:||Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||October 1, 2020|
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.
- The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules. [ Time Frame: All the data will be uploaded in 1 year. ]The accuracy, sensitivity and specificity of UGSR in differentiating benign from malignant thyroid nodules.
- The best UGSR in differentiating benign from malignant thyroid nodules. [ Time Frame: All the data will be uploaded in 1 year. ]The cut-off value of UGSR in differentiating benign from malignant thyroid nodules.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700762
|Contact: Chenke Xu, Doctoremail@example.com|
|The first people's hospital of Hangzhou|
|Hangzhou, Zhejiang, China, 310006|
|Contact: Chenke Xu, Doctor 8613606503599 firstname.lastname@example.org|
|Study Director:||Zhijiang Han, Doctor||The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine|