UltrasoundNCT04574258
Prospective Multicenter Study on Clinical Application of Sonozoid in Thyroid Tumor
An observational study of Ultrasound, run by Chinese PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound
- How many people
- 371 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with thyroid nodule who needs to biopsy or surgical resection;
Who may be able to join
- (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%)
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast-enhanced Ultrasound in Thyroid Tumor by Sonozoid
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.
- Conditions
- Ultrasound
- Keywords
- Thyroid carcinoma
- Medical subject headings
- Thyroid Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Oct 2020
- Primary completion1 May 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574258
- Sponsor's protocol ID
- S2020-300-01-01
- Status last verified
- Aug 2021
- First submitted
- 18 Sep 2020
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiao F, Li JM, Han ZY, Liu FY, Yu J, Xie MX, Zhou P, Liang L, Zhou GM, Che Y, Wang SR, Liu C, Cong ZB, Liang P. Multimodality US versus Thyroid Imaging Reporting and Data System Criteria in Recommending Fine-Needle Aspiration of Thyroid Nodules. Radiology. 2023 Jun;307(5):e221408. doi: 10.1148/radiol.221408.
PubMed 37367448
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Ultrasound in Thyroid Tumor by Sonozoid
- ClinicalTrials.gov ID
- NCT04574258
- Acronym / sponsor ID
- S2020-300-01-01
- Conditions
- Ultrasound
- Keywords
- Thyroid carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with thyroid nodule who needs to biopsy or surgical resection;
Key inclusion criteria (4 listed)
- (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%)
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of contrast-enhanced ultrasound in thyroid tumor by Sonazoid.
Time frame: 10 months
Pathology as a gold standard, to evaluate the diagnostic performance (sensitivity, specificity and accuracy) in thyroid tumor by Sonazoid.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Derived from this study: PubMed 37367448Xiao F, Li JM, Han ZY, Liu FY, Yu J, Xie MX, Zhou P, Liang L, Zhou GM, Che Y, Wang SR, Liu C, Cong ZB, Liang P. Multimodality US versus Thyroid Imaging Reporting and Data System Criteria in Recommending Fine-Needle Aspiration of Thyroid Nodules. Radiology. 2023 Jun;307(5):e221408. doi: 10.1148/radiol.221408.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Liang, Doctor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of contrast-enhanced ultrasound in thyroid tumor by Sonazoid. (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.