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

NCT ID: NCT04657341

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1012 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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This is a prospective, multicenter study.More than 1000 participants will enrolled.Most of them with CEUS,MRI and pathological follow up.When enhanced MRI is needed in the neoadjuvant cycle of patients, Sonazoid-CEUS examination is added at this time point, and postoperative pathology will be used as the gold standard, so as to compare the ability of the two imaging examinations in judging the effect of neoadjuvant chemotherapy.

Investigators will also record the parameter information of imaging examination, pathological type of pathological examination and immunohistochemical index, etc.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

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Ultrasound

Keywords

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breast

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* (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

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) 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ping Liang

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ping Liang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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S2020-300-01

Identifier Type: -

Identifier Source: org_study_id