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临床试验/NCT06649565
NCT06649565招募中不适用

Prospective Validation and Application of an Artificial Intelligence-based Model for Evaluating the Efficacy of Breast Cancer Patients After Neoadjuvant Therapy

Cancer Institute and Hospital, Chinese Academy of Medical Sciences2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Breast MRI radiomics characteristics of breast cancer patients during neoadjuvant therapy

研究概览

简要总结

Breast cancer has become the world's number one cancer. While its therapeutic efficacy is increasing, how to achieve non-invasive evaluation of the efficacy of neoadjuvant therapy (NAT) for breast cancer patients and thus avoid surgery has become a bottleneck problem that needs to be broken through in clinical diagnosis and treatment. Existing non-invasive evaluation strategies are limited to single-center, single-modality modeling, and have problems such as low performance and poor versatility. Therefore, in the early stage of this study, multi-modality breast cancer patient data from multiple centers across the country were collected and the establishment of an artificial intelligence (AI) efficacy prediction model was preliminarily completed. On this basis, this project intends to further improve the multi-center prospective validation study of the prediction model. The research results will help solve the scientific problem of non-invasive judgment of NAT efficacy in breast cancer patients and provide a new paradigm for the research of high-performance AI diagnosis and treatment auxiliary systems applicable to multiple centers.

详细描述

(1) Prospectively collect breast MRI original images (DCE and ADC sequences) and corresponding clinical and surgical pathological data of multi-center breast cancer patients before and after neoadjuvant treatment, store and transport them via mobile hard disks, and input the processed data into the established efficacy determination model stored in a dedicated cloud server; (2) Use artificial intelligence to automatically delineate the ROI area and extract the imaging genomics and deep learning features therein, and combine the clinical pathological characteristics of the patients to further prospectively verify the effectiveness of the established pCR efficacy determination model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who were treated in the above research centers between January 1, 2024 and October 31, 2025;
  • ≥18 years old, female, ECOG score ≤2;
  • Pathological biopsy confirmed invasive breast cancer;
  • AJCC (8th edition) stage I-III;
  • MRI imaging data before and after neoadjuvant therapy;
  • Planned mastectomy or breast-conserving surgery after neoadjuvant therapy, and postoperative pathological information obtained.

排除标准

  • Bilateral breast cancer, multiple lesions, or occult breast cancer;
  • Poor MRI data quality;
  • Patients who had received other anti-tumor treatments before enrollment;
  • Patients with other malignant tumors

结局指标

主要结局

Breast MRI radiomics characteristics of breast cancer patients during neoadjuvant therapy

时间窗: Breast cancer MRI images before neoadjuvant therapy and immediately after completing neoadjuvant therapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

PENG YUAN

Chief Physician

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (2)

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