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临床试验/NCT07692230
NCT07692230进行中(未招募)不适用

MRI-driven Multiomics Research on Precise Typing and Response Prediction of Luminal Breast Cancer

Fudan University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2026年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,000
试验地点
1
主要终点
Diagnostic performance of breast MRI for molecular subtyping of luminal breast cancer, with comparison to multiomics

研究概览

简要总结

Luminal breast cancer is characterized by marked heterogeneity, resulting in diverse treatment responses and long-term outcomes. This project aims to integrate MRI and multiomics data to achieve non-invasive molecular typing and precise response prediction. By linking imaging phenotypes with underlying molecular and pathological characteristics, the investigators will develop predictive models for treatment resistance, recurrence, and metastasis, ultimately supporting personalized treatment strategies and precision oncology.

详细描述

Luminal breast cancer represents the most common type of breast cancer, characterized by its intricate tumor heterogeneity that poses a significant challenge in clinical management due to resistance to endocrine therapy and high risk of long-term recurrence. It is significant for the accurate prediction of molecular subtypes and treatment response for luminal breast cancer. Our team has previously identified four molecular subtypes and seven pivotal molecules associated with luminal breast cancer utilizing multiomics techniques. The investigators posit that the integration of MRI-driven multiomics studies holds promise in achieving precise typing and response prediction for luminal breast cancer. This project intends to use multiomics molecular subtypes and key molecules as the gold standard to extract comprehensive quantitative features from diverse regions and levels utilizing MRI, thus facilitating non-invasive diagnosis. Additionally, our approach involves correlating MRI data with multiomics information to unveil the biological significance of imaging models at both pathological and molecular levels. Finally, the investigators aim to construct response prediction models through the fusion of multi-temporal MRI features and multiomics data across various scales, enabling precise forecasts of treatment resistance, recurrence, and metastasis. This initiative aims to enhance treatment decision-making and promote application transformation. This study will include a large-scale real-world retrospective and prospective population to validate and improve the effectiveness of model.

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

  • Histopathologically confirmed invasive luminal breast cancer (HR+/HER2-);
  • Patients who underwent breast MRI examination.

排除标准

  • Pathological biopsy performed prior to the baseline MRI examination;
  • Patients have received any form of prior treatment for the breast cancer;
  • History of other malignancies;
  • Incomplete or poor-quality MRI and/or pathological images;
  • Missing clinical data.

结局指标

主要结局

Diagnostic performance of breast MRI for molecular subtyping of luminal breast cancer, with comparison to multiomics

时间窗: 1 year

The primary outcome is the diagnostic performance of AI-assisted analysis for molecular subtyping of luminal breast cancer on contrast-enhanced breast MRI. Quantitative radiomic features and deep learning features are extracted from DCE-MRI, followed by classification into multiomics-defined molecular subtypes. Performance metrics include sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and area under the receiver operating characteristic curve (AUC). Participants must have undergone both breast MRI and multiomics profiling of tumor tissue. Performance metrics will be compared with those obtained from multiomics classification within the same participants to evaluate the relative diagnostic performance.

次要结局

  • Predictive performance of a multiomics model for treatment response and prognosis in luminal breast cancer(5 years)
  • Predictive Performance of Multiomics Model for Pathological Complete Response (pCR) in Luminal Breast Cancer(1 years)

研究者

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

Yajia Gu, MD

Director, Head of Radiology, Principal Investigator, Clinical Professor

Fudan University

研究点 (1)

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