NCT04657328

Prospective Multicenter Study on Clinical Application of Sonazoid in Breast Tumor

Contrast-enhanced Ultrasound in Breast Tumor by Sonazoid

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 181 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ultrasound

Timeline

• Start date: 2020-08-15
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2020-12-08
• Last updated: 2021-08-23

Locations

1 site across 1 country: China