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CompletedNCT04574258Updated Aug 10, 2021

Prospective Multicenter Study on Clinical Application of Sonozoid in Thyroid Tumor

An observational study in Ultrasound, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-10.

Sponsored by Chinese PLA General Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
371
Ages
18 Years and older
Sex
All
01

Study summary

Sonazoid as a new generation of ultrasound contrast agent. This study based on the features of Sonazoid specific angiography and high mechanical index, the role of Sonazoid in the differential diagnosis of thyroid benign and malignant tumors was explored.

Read the detailed description

Sonazoid as a new generation of ultrasound contrast agent, was liver specificity (Kupffer cells), macrophages at the very stable period, Kupffer imaging contrast enhancement effect for more than 1 hour, it is mainly used for focal liver lesions of blood vessels and Kupffer phase of ultrasonic imaging, facilitate early detection of small lesions (\< 1 cm). Until now, Sonazoid has been mainly focused on liver focal lesions.

CEUS is an effective imaging method to differentiate thyroid nodules, which can achieve diagnostic accuracy of 84\~92.5% based on features of low enhancement, uneven enhancement and circular enhancement. However, studies have shown overlapping findings between CEUS qualitative and quantitative criteria for the evaluation of benign and malignant nodules, limitations in the interpretation of tumor microvascular distribution, and no single indicator has sufficient sensitivity or specificity. Therefore, in the evaluation of thyroid nodules, the existing CEUS interpretation of the results is still limited, the need for a new model.

The existing contrast agents, Sonazoid stability is better, can tolerate relatively high mechanical index and penetration; The size of the microspheres was uniform, with 99.9% less than 7 m, most of which were between 2 and 4 m, and the median diameter of the microspheres was 2.6 m. The imaging was more uniform and clear, and the outstanding advantage was that high-frequency (7-20m) imaging could be realized, which was conducive to the exploration of small superficial lesions in patients. However, studies on Sonazoid in superficial organs such as thyroid were extremely rare.

In addition, Sonazoid microspheres is mononuclear phagocytes specificity contrast agents, main mononuclear phagocyte system including monocytes, connective tissue, lymph nodes and spleen macrophages, kupffer cells of the liver, dust cells of the lung, lymphoid tissue in the crisscross DCS etc. Most researches, both at home and abroad, have confirmed that the expression of Macrophages has long been Associated with the malignancy and lymph node metastasis, but negatively correlated with the prognosis. In thyroid carcinoma, tumor-associated Macrophages was significantly higher than that of benign Tumor and follicular adenoma.

Therefore, based on the features of Sonazoid specific angiography and high mechanical index, the role of Sonazoid in the differential diagnosis of thyroid benign and malignant tumors, the degree of tumor differentiation and the risk assessment of lymph node metastasis was explored.

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Conditions studied

  • Ultrasound

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Keywords

  • Thyroid carcinoma
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In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's enrollment of 371 is above the median of 172 across 261 observational studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients with thyroid nodule who needs to biopsy or surgical resection;

Inclusion criteria

  • (1) The thyroid nodules were mostly solid or solid.
  • (2) Patients with thyroid nodules to be punctured or surgically removed;
  • (3) Ability to understand, sign informed consent and agree to participate in the investigator;
  • (4) No significant risk of bleeding (platelet ≥50x109/L, prothrombin activity ≥50%)

Exclusion criteria

Exclusion Criteria:

  • (1) Patients with a history of neck surgery;
  • (2) Women during pregnancy and lactation;
  • (3) Ultrasound contrast agent exposure history within 1 month;
  • (4) Those who are known to be allergic to ultrasound contrast agents;
  • (5) Uncontrolled heart failure.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
371 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Diagnostic performance of contrast-enhanced ultrasound in thyroid tumor by Sonazoid.

    Pathology as a gold standard, to evaluate the diagnostic performance (sensitivity, specificity and accuracy) in thyroid tumor by Sonazoid.

    Time frame: 10 months

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Study locations

1 site
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04574258
Lead sponsor
Chinese PLA General Hospital
Responsible party
Ping Liang (Department of Interventional Ultrasound, Chinese PLA General Hospital) — Principal investigator
First posted
Oct 5, 2020
Start date
Oct 1, 2020
Primary completion
May 1, 2021
Completion
Aug 1, 2021
Last update
Aug 10, 2021

Study contacts

Ping Liang, Doctor
principal investigator · Chinese PLA General Hospital

Oversight

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

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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