Prospective Multicenter Study on Clinical Application of Sonazoid in Breast Tumor

Ultrasound Clinical Trial

Official title:

Contrast-enhanced Ultrasound in Breast Tumor by Sonazoid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04657328
• Other study ID #: S2020-300
• Status: Recruiting
• Start date: August 15, 2020
• Est. completion date: October 2021

Study information

• Verified date: August 2021
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Doctor
• Phone: 8601066939530
• Email: jiemi301[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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 breast benign and malignant tumors was explored.

Description:

This trial is a prospective, multi-center study.With pathology as the gold standard, based on quantitative and qualitative analysis, Sonazoid-CEUS was compared with MRI to explore the diagnostic efficacy (accuracy, sensitivity and specificity) of Sonazoid-CEUS for breast tumor in different pathological types. Investigators will also record the parameter information of imaging examination, pathological type of pathological examination and immunohistochemical index.Contrast-enhanced ultrasound includes lesion location, initial peak tumor volume, 1-minute tumor volume, 2-minute tumor volume, and 5-minute tumor volume, as well as the time for contrast enhancement, contrast agent clearance, and contrast agent clearance.Whether there is no enhancement area in the lesion after contrast enhancement, shape after contrast enhancement, edge after contrast enhancement, order of enhancement, uniformity of enhancement, intensity enhancement, pattern of enhancement, clear boundary after contrast enhancement, aspect ratio after contrast enhancement, etc.The magnetic field strength of the equipment is planned to be recorded in the enhanced MRI information, the name of the MRI contrast agent, the lesion location, the size of the LESION, and the scanning performance are enhanced (lump-like enhancement, non-lump-like enhancement, point-like enhancement), time-signal intensity enhancement curve, DWI signal, ADC value, etc.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 181
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Ultrasound

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of contrast-enhanced ultrasound in breast tumor by Sonazoid.	Pathology as a gold standard,to evaluate the diagnostic performance in breast tumor by Sonazoid.	10 months