跳至主要内容
临床试验/NCT07510867
NCT07510867尚未招募不适用

A Prospective Clinical Study on the Application of 18F-FAPI PET Imaging Combined With Multi-parameter MRI in the Diagnosis of Gastric Cancer

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
230
试验地点
1
主要终点
Diagnostic efficacy

研究概览

简要总结

The purpose of this study was to evaluate the diagnostic efficacy and prognostic value of 18F-FAPI PET/CT combined with multiparameter MRI in gastric cancer.

详细描述

Evaluation of the diagnostic and staging efficacy of 18F-FAPI PET/CT combined with multiparametric MRI This study aims to evaluate the sensitivity, specificity, and accuracy of 18F-FAPI PET/CT combined with multiparametric MRI in gastric cancer patients, providing a basis for clinical application. By performing 18F-FAPI PET/CT and multiparametric MRI imaging on gastric cancer patients, relevant data were collected and analyzed to assess their performance in early diagnosis, staging, and recurrence monitoring. The goal is to provide a scientific basis for clinical physicians in the diagnosis, precise staging, and treatment decision-making of gastric cancer.

2.1.2 Comparative Study of 18F-FAPI PET/CT and Contrast-Enhanced MRI A comparative study of 18F-FAPI PET/CT and contrast-enhanced MRI in gastric cancer patients to evaluate the differences in tumor detection sensitivity, specificity, and accuracy among various imaging modalities. The study aims to clarify their advantages in clinical applications for gastric cancer. The research will focus on analyzing the differences in tumor size, location, metastasis, and pathological characteristics detected by each imaging technique, and explore the potential of 18F-FAPI PET/CT combined with multiparametric MRI in improving the diagnostic accuracy and early detection of gastric cancer.

2.1.3 Analysis of diagnostic differences in gastric cancer subgroups using 18F-FAP PET/CT combined with multiparametric MRI Subgroup analysis was performed based on pathological type, stage, and molecular subtype, stratified by disease pathological type, stage (early/progressive/advanced), and molecular subtype, to evaluate the differences in sensitivity and specificity of 18F-FAPI PET/CT combined with multiparameter MRI across different patient populations. This study will help identify which specific types of gastric cancer patients are more likely to benefit from 18F-FAPI PET/CT, thereby providing a basis for the development of individualized treatment plans.

2.1.4 Evaluation of Multimodal Imaging Combinations in Predicting Gastric Cancer Prognosis Based on TNM staging and PERCIST criteria, this study evaluates the post-treatment reassessment, efficacy prediction, and prognostic assessment (AUC comparison of PFS/OS) of 18F-FAPI PET/CT combined with multiparametric MRI in gastric cancer. The research aims to analyze the multimodal imaging combination's monitoring capability for tumor response post-treatment and its value in prognostic evaluation, providing clinicians with a more precise tool for therapeutic outcome assessment. It tracks the time from diagnosis to specific events (e.g., CR, PR, SD, PD, recurrence, death) in gastric cancer patients to identify influencing factors. Survival rates over time are plotted using Kaplan-Meier curves to visually compare survival differences across groups. Additionally, Cox proportional hazards model-based multivariate regression quantifies the contribution of factors such as age and pathological stage to survival risk, aiding clinical decision-making.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suspected or diagnosed with gastric cancer
  • 18F-FAPI PET/CT has been performed
  • Gastric MRI with both non-contrast and contrast-enhanced scans performed

排除标准

  • Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;
  • Severe uncontrollable diseases or active infections;
  • Ineligible participants who cannot provide informed consent for the study;
  • Patients with suboptimal image quality in 18F-FAPI PET/CT
  • Patients with suboptimal MRI image quality enhancement

结局指标

主要结局

Diagnostic efficacy

时间窗: through study completion, an average of 1.5 year

Sensitivity, specificity, positive and negative predictive value of 18F-OC PET/CT and PET/MR Imaging in neuroendocrine neoplasms

次要结局

  • Standard uptake value (SUV)of tumor(through study completion, 3-4 years)
  • Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients(through study completion, 3-4 years)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验