跳至主要内容
临床试验/NCT07051083
NCT07051083招募中不适用

Intelligent Diagnosis of Bladder Cancer Staging and Prediction of New Adjuvant Chemotherapy Efficacy Based on Deep Learning and Transfer Learning in Ultrasound-Magnetic Resonance-Pathology Multimodal Multiscale

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 480 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
480
试验地点
1
主要终点
Detection of Muscle Invasion in Bladder Cancer

研究概览

简要总结

Bladder cancer is the most common malignant tumor of the urinary system. The presence or absence of muscle invasion in early bladder cancer is an independent prognostic factor. The involvement of muscle invasion affects the choice of surgical methods and treatment. Preoperatively, the precise assessment of bladder cancer staging has important practical value. A more accurate preoperative assessment of bladder cancer staging can reduce overtreatment and provide a favorable basis for clinicians to choose more reasonable and effective surgical methods. Clinically, there has been a longstanding desire to diagnose the staging of bladder cancer through a simple, convenient, effective, and non-invasive examination. As relevant research progresses, a multi-omics diagnostic model will be beneficial in improving diagnostic efficiency. This project aims to establish a multi-omics artificial intelligence system based on deep learning and transfer learning to accurately diagnose the staging of bladder cancer and predict the efficacy of neoadjuvant chemotherapy. This system will assist in clinical treatment decision-making.

详细描述

Research Content

  1. Establishment of Ultrasound and Magnetic Resonance Imaging-Pathology-Clinical Dataset: This project aims to include medical records diagnosed through ultrasound and magnetic resonance imaging. Combining results from cytopathology or tissue pathology, the project will collect ultrasound images of the bladder, magnetic resonance images of the bladder, pathology images, and clinically relevant follow-up data. Tumor tissue specimens will be collected for immunohistochemical fluorescence staining. Participants with indistinct imaging findings or those with other primary malignant tumors will be excluded. The goal is to establish an ultrasound and magnetic resonance imaging-pathology-clinical dataset.
  2. Establishment of an Artificial Intelligence System for Precise Diagnosis of Bladder Cancer Staging and Prognosis based on Ultrasound Imaging: Collecting clinical baseline information, surgical pathology, and ultrasound images of enrolled subjects. The ultrasound images will undergo homogenization processing. Utilizing algorithms based on U-Net, Transformer, and attention mechanisms for tissue segmentation and feature extraction, a deep learning model based on convolutional neural networks will be established for precise diagnosis of bladder cancer staging and prognosis:

Construction of a mathematical model for staging bladder cancer using ultrasound contrast: Using convolutional neural networks for deep learning to build a mathematical model for staging bladder cancer. Developing an artificial intelligence diagnostic system for ultrasound contrast images based on deep learning and mathematical models to determine whether bladder cancer has muscle invasion.

Construction of a mathematical model to discriminate prognosis features of bladder cancer using ultrasound imaging: Automatically delineating target areas and extracting ultrasound image features of bladder cancer lesions using new artificial intelligence technology - convolutional neural networks to build a model for evaluating the prognosis of bladder cancer lesions and achieving accurate prognosis diagnosis. 3. Establishment of an Artificial Intelligence System for the Joint Diagnosis of Bladder Cancer and Staging based on Ultrasound and Magnetic Resonance Imaging with Pathology: Based on bladder ultrasound, magnetic resonance imaging, and pathology image data, the baseline information of study subjects will be digitized. Ultrasound images, magnetic resonance images, and pathology images will undergo homogenization processing. Utilizing algorithms based on U-Net, Transformer, and attention mechanisms for segmentation and feature extraction of bladder ultrasound images, magnetic resonance images, and pathology images, a deep learning model based on convolutional neural networks will be established for the precise diagnosis of bladder cancer staging and prognosis:

Construction of a mathematical model for joint pathology-based staging of bladder cancer using ultrasound and magnetic resonance imaging: Using convolutional neural networks for deep learning to build a mathematical model for staging bladder cancer. Based on the mathematical model, continuously optimizing algorithms, developing multi-omics, multidimensional artificial intelligence diagnostic systems based on ultrasound images, magnetic resonance images, pathology images, and clinical features, achieving accurate diagnosis of bladder cancer staging and prognosis prediction models.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Ultrasound and other imaging examinations (CT, MR, etc.) suggest bladder masses and are suspicious for bladder cancer patients.
  • The bladder is well filled, and no allergic reactions to ultrasound contrast agents are found.
  • No surgery or radiotherapy/chemotherapy has been performed.
  • Patients who meet the indications for surgical resection and are planned for surgical treatment, including one of the following:
  • Clinical symptoms consistent with suspected bladder cancer (such as gross hematuria, etc.);
  • Patients with confirmed primary or recurrent bladder cancer by cystoscopic biopsy;
  • Rapid urine cytology and urine cytology FISH testing suggest malignancy.

排除标准

  • Individuals unable to tolerate surgery;
  • Individuals allergic to ultrasound contrast agents, unable to undergo ultrasound contrast examination;
  • Unsuccessful preoperative ultrasound contrast examination or non-compliant patients;
  • Postoperative pathology does not indicate bladder cancer;
  • Patients who have undergone chemotherapy or radiation therapy.

结局指标

主要结局

Detection of Muscle Invasion in Bladder Cancer

时间窗: Perform contrast-enhanced ultrasound (CEUS) examination within 2 weeks before the procedure.

To evaluate the preoperative staging of bladder cancer,whether it is non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancers (MIBC)

次要结局

  • Evaluate the Diagnostic Performance of Deep Learning and Transfer Learning in Preoperative Prediction of Muscle-Invasive Status in Bladder Cancer(The patient should return for follow-up at 3 months postoperatively)

研究者

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

Qiyun Ou

Dr.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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