Prospective Multicenter Study on Clinical Application of Sonozoid in Thyroid Tumor
Contrast-enhanced Ultrasound in Thyroid Tumor by Sonozoid
1 other identifier
observational
371
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedAugust 10, 2021
August 1, 2021
7 months
September 18, 2020
August 7, 2021
Conditions
Keywords
Outcome Measures
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.
10 months
Eligibility Criteria
Patients with thyroid nodule who needs to biopsy or surgical resection;
You may qualify if:
- (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%)
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (1)
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.
PMID: 37367448DERIVED
Biospecimen
FNA or CNB in thyroid carcinoma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ping Liang, Doctor
Chinese PLA General Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Interventional Ultrasound
Study Record Dates
First Submitted
September 18, 2020
First Posted
October 5, 2020
Study Start
October 1, 2020
Primary Completion
May 1, 2021
Study Completion
August 1, 2021
Last Updated
August 10, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share