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Набор скоро начнётся NCT07510867

18F-FAPI PET/CT and MRI in Gastric Cancer

Наблюдательное Gastric Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: patients with suspected or confirmed gastric cancer who have undergone 18F-FAPI PET/CT and MRI (non-contrast + contrast-enhanced scans).
Кому может быть актуально
Состояния в реестре: Gastric Cancer. Базовые параметры: 20 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест patients with suspected or confirmed gastric cancer who have undergone 18F-FAPI PET/CT and MRI (non-contrast + contrast-enhanced scans)
    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

Первичные конечные точки

  • Diagnostic efficacy [Срок оценки: through study completion, an average of 1.5 year]
Вторичные конечные точки (2)
  • Standard uptake value (SUV)of tumor [Срок оценки: through study completion, 3-4 years]
  • Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients [Срок оценки: through study completion, 3-4 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Pet /Ct/Mri — Ханчжоу

Идентификаторы

NCT: NCT07510867 · [2026B]IIT. No.0118

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗