NCT04661436

Multimodal Imaging Evaluation System of Axillary Lymph Node Staging and Treatment Strategy for Breast Cancer Neoadjuvant Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Contrast-Enhanced Ultrasound	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-12-10
• Last updated: 2020-12-10