Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04574258 |
| Other study ID # |
S2020-300-01-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
August 1, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Chinese PLA General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
