Sonazoid Contrast-enhanced Ultrasound in Assessing Effectiveness of Neoadjuvant Chemotherapy in Breast Cancer Patients.

NCT04657341 | Unknown

• 1 other identifier: S2020-300-01
• Study Type: observational
• Target: 1,012
• 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 assessing effectiveness of neoadjuvant chemotherapy in breast cancer patients was explored.

Conditions

Ultrasound

Keywords

breast

Outcome Measures

Primary Outcomes (1)

• Sonazoid contrast-enhanced ultrasound in assessing effectiveness of neoadjuvant chemotherapy in breast cancer patients.

  Pathology as a gold standard,to compare the diagnostic performance between contrast-enhanced ultrasound and other contrast-enhanced imaging in neoadjuvant chemotherapy in breast cancer patients.

  10 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients who plan neoadjuvant chemotherapy and conform to contrast-enhanced ultrasound, enhanced mri, and surgical indications.

You may qualify if:

• (1) Refer to the guidelines and specifications for diagnosis and treatment of breast cancer, and it is clearly identified as breast cancer by pathological biopsy.
• (2) Plan to implement NAC therapy;
• (3) All patients and their family members signed informed consent forms, which were approved by the hospital medical Ethics Committee

You may not qualify if:

• (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) Intolerance to neoadjuvant chemotherapy;
• (4) Poor compliance with chemotherapy treatment;
• (5) Patients who cannot receive contrast agent MRI examination
• (6) Arteriovenous (left and right) shunt patients in the heart and lungs;
• (7) Mental disorders or mental disorders;
• (8)Patients with serious heart disease or lung disease;
• (9)Pet-pregnant, possibly pregnant or lactating;
• (10)In addition, the researcher or the researcher thinks that the patient is 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

Location

Study Officials

• Ping Liang, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

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

Record last verified: 2020-12

Locations

CN (1)