CClinicalTrials.gg
Status unknownNCT03700762Updated Oct 9, 2018

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

An observational study in Thyroid Nodule, sponsored by First People's Hospital of Hangzhou. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by First People's Hospital of Hangzhou · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thyroid Nodule

Keywords

  • Thyroid Nodule
  • differential diagnosis
03

In context

Thyroid Nodule

200 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 78 observational studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

First People's Hospital of Hangzhou is the lead sponsor of 70 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • patients diagnosed as thyroid nodule.
  • homo-echogenicity of normal thyroid tissue.
  • able and willing to comply with all study requirements.

Exclusion criteria

Exclusion Criteria:

  • nodules are mainly cystic or calcified.
  • pathology confirmed Hashimoto's thyroiditis.
  • unable or unwilling to comply with all study requirements.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: All the data will be uploaded in 1 year.

Secondary outcomes

  1. The best UGSR in differentiating benign from malignant thyroid nodules.

    The cut-off value of UGSR in differentiating benign from malignant thyroid nodules.

    Time frame: All the data will be uploaded in 1 year.

07

Study locations

1 site
  • The first people's hospital of Hangzhou
    Hangzhou, Zhejiang 310006, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03700762
Lead sponsor
First People's Hospital of Hangzhou
Responsible party
Sponsor
First posted
Oct 9, 2018
Start date
Oct 1, 2018 (estimated)
Primary completion
Oct 1, 2019 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
Oct 9, 2018

Study contacts

Chenke Xu, Doctor
Contact
113614988@qq.com
8613606503599
Zhijiang Han, Doctor
study director · The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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