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In view of the lack of systematic curative effect prediction and early evaluation indicators for breast cancer neoadjuvant chemotherapy, the effective fusion of CEUS(contrast-enhanced ultrasound) and MRI is realized, and a multi-modal standardized evaluation system of NAT based on the dynamics across time and full cycle is constructed, in order to find the predictive effect and early evaluation of NAT. Means to improve the accuracy of NAT patient selection, treatment course selection, and efficacy evaluation, to achieve controllable and individualized and precise NAT, thereby improving efficacy, reducing unnecessary treatment adverse reactions, guiding pathological materials, reducing medical costs, and ultimately improving breast cancer The patient's DFS and OS. In addition, for patients with axillary lymph node cN0 before and after neoadjuvant or descending after neoadjuvant, the evaluation system is used to explore the feasibility, safety, and effectiveness of replacing sentinel lymph node biopsy or carrying out sentinel lymph node biopsy, which is a useful strategy for axillary lymph node management in such patients. Develop a theoretical foundation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-Enhanced Ultrasound | Diagnostic Test | The research will study the qualitative analysis indicators of contrast-enhanced ultrasound, including: enhancement uniformity, enhanced range, presence or absence of enhancement defect area, presence or absence of nourishing blood vessels, etc.; and quantitative analysis indicators, including: peak time, peak intensity, rising slope, Area under the curve, etc., analyze the correlation between the changes of various parameters before and after neoadjuvant treatment(NAT) and the pathological response of patients, and try to find indicators and cut-off values that can predict and early evaluate the efficacy. This study will study the qualitative and quantitative parameters of MRI-enhanced scanning and the changes of DWI parameters, analyze the correlation between the parameters of patients before and after NAT and pathological response, and try to find indicators and cut-off values that can predict and early evaluate the efficacy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative analysis parameters and cut-off values of contrast-enhanced ultrasound prediction and early evaluation of NAT efficacy; | By studying the qualitative analysis indicators of contrast-enhanced ultrasound, including: enhancement uniformity, enhanced range, presence or absence of enhancement defect area, presence or absence of nourishing vessels, etc.; and quantitative analysis indicators, including: peak time, peak intensity, rising slope, under the curve Area, etc., analyze the correlation between the changes of the parameters before and after NAT and the pathological response. | Estimated up to 2 year |
| Enhanced MRI prediction and DWI for early evaluation of NAT efficacy, and enhanced quantitative analysis parameters and cut-off values | By studying the qualitative and quantitative parameters of MRI-enhanced scanning and the changes of DWI parameters, the correlation between the parameters before and after NAT and the pathological response of patients is analyzed. | Estimated up to 2 year |
| Able to predict and assess the stage of axillary lymph nodes after NAT and guide the development of diagnostic criteria for treatment strategies | Combining the high sensitivity of ultrasound in the recognition of superficial lymph nodes, the feasibility of contrast-enhanced ultrasound in the identification, location and diagnosis of sentinel lymph nodes in breast cancer, and the integrity of MRI, to discuss the formulation of multi-imaging systems for the treatment of axillary lymph nodes in patients with lymph node degeneration after NAT The feasibility, safety and effectiveness of clinical application. | Estimated up to 2 year |
| Construct a multi-modal and multi-parameter evaluation system and its standards that can predict and early evaluate the efficacy of NAT. | Based on the above three research results, a mathematical model is established, a multi-modal and multi-parameter evaluation system combining multiple images is constructed, and the strengths are complemented to establish an economic and efficient evaluation index system and standardized process. |
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Inclusion Criteria:
Age and gender: 18 to 70 years old, female;
ECOG systemic state 0~1;
Screening examinations, including medical history, vital signs measurement, general physical examination, laboratory examinations (blood routine, urine routine, blood biochemistry, blood electrolytes, full set of pre-transfusion, etc.), electrocardiogram, heart and abdomen color Doppler ultrasound, head, chest, Abdominal CT and bone scan to determine whether the subjects are in good health and have distant metastases;
According to the RECIST1.1 standard, at least one measurable lesion exists;
Invasive breast cancer confirmed by preoperative biopsy pathological examination, clinical stage is II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to the American Joint Committee on Cancer (AJCC) standard] Breast cancer patients;
The functional level of organs must meet the following requirements:
Patients with known hormone receptor status.
Patients with negative serum pregnancy tests and patients with reproductive potential must agree to use effective non-hormonal contraceptive methods during treatment and at least 6 months after the last use of the test drug.
During the trial period and within 6 months after the trial, female subjects should take medically acceptable or reliable contraceptive measures;
Subjects understand the test procedures, voluntarily comply with the requirements of the test protocol, and agree to participate in the test by signing an informed consent form approved by the ethics committee of the participating center.
Exclusion Criteria:
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Invasive breast cancer confirmed by preoperative biopsy pathological examination, clinical stage is II-III.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Luo, Master | Contact | 17740209986 | Milton-lj@hotmail.com | |
| Jie Chen, Master | Contact | 18628263734 | Chenjie20201019@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Luo, Master | Sichuan Provincial People's Hospital | Principal Investigator |
| Jie Chen, Master | Sichuan Provincial People's Hospital | Study Director |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Estimated up to 2 year |
| D017437 |
| Skin and Connective Tissue Diseases |