Prospective Multicenter Study on Clinical Application of Sonazoid in Breast Tumor

NCT04657328 | Unknown

• 1 other identifier: S2020-300
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 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 breast benign and malignant tumors was explored.

Conditions

Ultrasound

Keywords

breast

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Conventional ultrasonography suggested definite lesions in the breast;
• In addition to conventional ultrasound, there is also enhanced MRI examination;
• There are no contraindications for puncture biopsy, and pathological examination (cytology, histology) is planned to examine the patients with target lesions
• Patients volunteered to participate in the study and signed informed consent.-

You may not qualify if:

• Those who are known to be allergic to ultrasound contrast agents;
• 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.)
• Arteriovenous (left and right) shunt patients in the heart and lungs
• Patients with serious heart disease or serious lung disease
• Patients who are pregnant, possibly pregnant or lactating
• Patients who cannot receive contrast agent MRI
• In addition, the investigator or the patient that the investigator considers not suitable to participate in this study

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

• Lang 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

CNB in breast tumor

Study Officials

• Ping Liang, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yu, Doctor

CONTACT

8601066939530; jiemi301@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: December 8, 2020
• Study Start: August 15, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)