Prospective Multicenter Study on Clinical Application of Sonazoid in Breast Tumor

Contrast-enhanced Ultrasound in Breast Tumor by Sonazoid

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.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound

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.

• Study Type: Observational
• Enrollment (Anticipated): 181

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. Conventional ultrasonography suggested definite lesions in the breast;
2. In addition to conventional ultrasound, there is also enhanced nuclear magnetic 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: September 26, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: breast
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: S2020-300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No