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临床试验/NCT07389200
NCT07389200尚未招募不适用

Application of Multimodal MRI-based Radiomics in Histological Grading and Prognostic Assessment of Breast Cancer

Hao Xu0 个研究点目标入组 400 人开始时间: 2028年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
主要终点
Patients with pathologically confirmed breast cancer who underwent DCE-MRI were included. Radiomic features were extracted, and seven machine learning algorithms were utilized to construct predictive model.The AUC served as the evaluation metric

研究概览

简要总结

In addition to TNM staging, the current management of breast cancer is based on conventional pathological features that categorize the disease into three molecular subtypes, each with significant prognostic implications in clinical practice: human epidermal growth factor receptor 2 (HER2)-positive, luminal (hormone receptor-positive and HER2-negative), and triple-negative breast cancers. The overexpression or amplification of HER2 is observed in 10-15% of breast cancer cases. This phenomenon often correlates with a more aggressive tumor behavior while also demonstrating an increased responsiveness to HER2-targeted therapies. However, the use of highly effective anti-HER2 drugs can significantly enhance the survival outcomes of these patients. Additionally, the expression status of HER2 is critical in determining the necessity for targeted therapy. Therefore, preoperative assessment of HER2 expression status has important therapeutic implications. Currently, clinical methods for assessing HER2 status in breast cancer before surgery include immunohistochemistry (IHC) tests and fluorescence in situ hybridization (FISH) measurements performed on core-needle biopsy specimens. However, these biopsy sampling techniques have inherent limitations, including sampling bias and an inability to fully represent intratumor heterogeneity. Additionally, the biopsy procedure can be uncomfortable and carries certain risks for patients. Tumour heterogeneity generally refers to the variations in angiogenesis, metabolism, gene expression, and other biological characteristics among tumors. Intratumoral heterogeneity (ITH) can manifest as signal differences in radiological images at the macro level. Investigators hypothesized that significant differences in biological characteristics and behavior exist between HER2-positive (HER2+) and HER2-negative (HER2 -) breast cancers, allowing for the distinction of these two types of tumours by identifying specific imaging features that reflect ITH.

Dynamic contrast-enhanced MRI (DCE-MRI) is an effective imaging modality that provides temporal information regarding the dynamics of contrast agents in suspicious lesions while maintaining acceptable spatial resolution. It is particularly sensitive in detecting breast cancer lesions, especially those in dense breast tissue. DCE-MRI can indirectly reflect abnormal tumor vascular proliferation through the hemodynamic characteristics of the lesions. Radiomics is an emerging technology that involves extracting quantitative and reproducible features from medical images using high-throughput, sophisticated modalities that are often challenging to identify or quantify visually. These features, which may be linked to specific diseases, are analyzed using statistical or machine learning (ML) algorithms to create predictive models for tumor diagnosis, grading, efficacy evaluation, and prognosis prediction. ML has two important advantages over traditional statistical models. The goal is to reduce decision time during diagnosis and generally achieve greater diagnostic accuracy. As demonstrated in breast cancer diagnosis, ML can significantly improve cancer risk prediction by identifying complex patterns in large amounts of clinical data. Despite the great potential of ML, it still faces several obstacles in its clinical application. A major challenge is a lack of interpretability-many ML models operate like "black boxes", making it difficult for clinicians to understand and trust their decision-making processes. Furthermore, the performance of the model depends heavily on the quality and representativeness of the training data. ML methods often require larger data sets than traditional clinical studies.

Thus, this study aimed to develop a radiomics-based ML model that could predict the HER2 status of breast cancers in a non-invasive manner using DCE-MRI images. Additionally, the Shapley Additive Explanation (SHAP) algorithm was employed to analyze the contribution of the variables included in the model, providing valuable insights for formulating more accurate preoperative treatment plans for patients with breast cancers.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Histopathological diagnosis of breast cancer by surgical or biopsy pathology;
  • Availability of DCE-MRI within two weeks before surgery
  • No prior treatment before baseline DCE-MRI examination.

排除标准

  • Less than 5 mm of long diameter of the lesion
  • Severe motion artifacts
  • Missing or incomplete essential data
  • Anti-tumor treatment before MRI

研究组 & 干预措施

Breast Cancer

干预措施: DCE-MRI (Other)

结局指标

主要结局

Patients with pathologically confirmed breast cancer who underwent DCE-MRI were included. Radiomic features were extracted, and seven machine learning algorithms were utilized to construct predictive model.The AUC served as the evaluation metric

时间窗: From enrollment to the end of treatment at 8 weeks

The AUC served as the primary evaluation metric for identifying the optimal model. A comprehensive model evaluation was conducted, which included AUC, accuracy, sensitivity, specificity

F1 score

时间窗: From enrollment to the end of treatment at 8 weeks

F1 score, with validation on an independent cohort.

次要结局

  • histopathological diagnosis of breast cancer by surgical or biopsy pathology(From enrollment to the end of treatment at 8 weeks)

研究者

发起方
Hao Xu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hao Xu

Clinical Professor of Department of Radiology, Sichuan Cancer Hospital & Institute

Sichuan Cancer Hospital and Research Institute

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