Multimodal Imaging Evaluation System of Axillary Lymph Node Staging and Treatment Strategy for Breast Cancer Neoadjuvant Therapy (MIES-BCNAT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Contrast-Enhanced Ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Jun Luo, Master; Phone Number: 17740209986; Email: Milton-lj@hotmail.com
• Study Contact Backup: Name: Jie Chen, Master; Phone Number: 18628263734; Email: Chenjie20201019@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Invasive breast cancer confirmed by preoperative biopsy pathological examination, clinical stage is II-III.

Description

Inclusion Criteria:

1. Age and gender: 18 to 70 years old, female;
2. ECOG systemic state 0~1;
3. 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;
4. According to the RECIST1.1 standard, at least one measurable lesion exists;
5. 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;

6. The functional level of organs must meet the following requirements:

   1. Blood routine ANC≥1.5×10 9/L; PLT≥90×10 9/L; Hb≥90 g/L;
   2. Blood biochemistry TBIL≤1.5×ULN; ALT and AST≤2×ULN; BUN and Cr ≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula);
   3. Heart color Doppler ultrasound LVEF≥50%;
   4. 12-lead ECG Fridericia method corrected QT interval (QTcF) female <470 ms.
7. Patients with known hormone receptor status.
8. 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.
9. During the trial period and within 6 months after the trial, female subjects should take medically acceptable or reliable contraceptive measures;
10. 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:

1. Allergic physique, those who are known to be allergic to the components of the test drug (inquiry); those who have a history of allergies to ultrasound contrast agents (sulfur hexafluoride microbubbles) and any contrast agent in enhanced magnetic resonance (inquiry) ；
2. Inflammatory breast cancer; metastatic breast cancer (stage IV)
3. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency and a history of organ transplantation;
4. Have ever suffered from any heart disease, including: 1) angina pectoris; 2) arrhythmia requiring medication or clinical significance; 3) myocardial infarction; 4) heart failure; 5) any person judged to be unsuitable Other heart diseases participating in this trial.
5. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period.
6. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.).
7. Have a clear history of neurological or mental disorders, including epilepsy or dementia.
8. Any other situation that the researcher considers inappropriate to participate in this research.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	Estimated up to 2 year

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital
• Investigators: Principal Investigator: Jun Luo, Master, Sichuan Provincial People's Hospital; Study Director: Jie Chen, Master, Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (ACTUAL): December 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Breast cancer; neoadjuvant therapy; axillary lymph nodes; Evagination
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MIES-BCNAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No