Clinical trial NCT04657341: Sonazoid Contrast-enhanced Ultrasound in Assessing Effectiveness of Neoadjuvant Chemotherapy in Breast Cancer Patients.
Official title: Sonazoid Contrast-enhanced Ultrasound in Assessing Effectiveness of Neoadjuvant Chemotherapy in Breast Cancer Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasound
Keywords: breast
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 1012
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients who plan neoadjuvant chemotherapy and conform to contrast-enhanced ultrasound, enhanced mri, and surgical indications.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sonazoid contrast-enhanced ultrasound in assessing effectiveness of neoadjuvant chemotherapy in breast cancer patients.
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Ping Liang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: