Clinical trial · Observational
Prospective Multicenter Study on Clinical Application of Sonazoid in Breast Tumor
Contrast-enhanced Ultrasound in Breast Tumor by Sonazoid
NCT04657328CI-TRIAL-00053453unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 breast benign and malignant tumors was explored.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ultrasound | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic performance of contrast-enhanced ultrasound in breast tumor by Sonazoid.
- timeFrame
- 10 months
- description
- Pathology as a gold standard,to evaluate the diagnostic performance in breast tumor by Sonazoid.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Conventional ultrasonography suggested definite lesions in the breast; 2. In addition to conventional ultrasound, there is also enhanced MRI examination; 3. There are no contraindications for puncture biopsy, and pathological examination (cytology, histology) is planned to examine the patients with target lesions 4. Patients volunteered to participate in the study and signed informed consent.- Exclusion Criteria: 1. Those who are known to be allergic to ultrasound contrast agents; 2. The subject has a history of allergy to eggs or egg products (i.e. skin rash, dyspnea, swelling of the mouth or throat, hypotension or shock, etc.) 3. Arteriovenous (left and right) shunt patients in the heart and lungs 4. Patients with serious heart disease or serious lung disease 5. Patients who are pregnant, possibly pregnant or lactating 6. Patients who cannot receive contrast agent MRI 7. In addition, the investigator or the patient that the investigator considers not suitable to participate in this study
References
Publications (1)
- DERIVEDLang M, Liang P, Shen H, Li H, Yang N, Chen B, Chen Y, Ding H, Yang W, Ji X, Zhou P, Cui L, Wang J, Xu W, Ye X, Liu Z, Yang Y, Wei T, Wang H, Yan Y, Wu C, Wu Y, Shi J, Wang Y, Fang X, Li R, Yu J. Head-to-head comparison of perfluorobutane contrast-enhanced US and multiparametric MRI for breast cancer: a prospective, multicenter study. Breast Cancer Res. 2023 May 30;25(1):61. doi: 10.1186/s13058-023-01650-3. PMID 37254149