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临床试验/NCT05508126
NCT05508126招募中不适用

Diagnostic Accuracy of Multi-parametric MRI and Dual-energy CT in Gastric Cancer: a Paired Validating Confirmatory Study

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2021年11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
222
试验地点
1
主要终点
Diagnostic performance of DECT and mpMRI in tumor staging assessment

研究概览

简要总结

Accurate preoperative staging of gastric cancer is of major importance for guiding therapeutic decision-making, preventing both under- and over-treatment. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and dual-energy computed tomography (DECT) in gastric cancer.

详细描述

Gastric cancer is the leading cause of cancer-related death worldwide. The therapeutic approach to gastric cancer is strongly dependent on preoperative stage. The crucial role of gastric cancer imaging lies in implementing individualized treatment regimens according to various stages of tumor.

CT scanning has been recommended as the first-line image modality for preoperative evaluation of gastric cancer by the 8th AJCC staging manual. However, for traditional CT, the accuracy of staging is highly variable and the sensitivity of early gastric cancer detection is relatively low. Recently, DECT has been increasingly used in clinical practice due to its powerful post-processing technique. A recent small sample study showed that monoenergetic images at 40 KeV improved lesion depiction and higher T stage accuracy for gastric cancer. Therefore, this study chose DECT instead of traditional CT to explore the diagnostic performance in preoperative staging.

Historically, the role of MRI in gastric cancer has been limited, and the guidelines have not yet recommended MRI as a first-line examination scheme. But with the continuous technical improvements for abdominal imaging (e.g. breath-hold sequences and high Resolution diffusion-weighted imaging (DWI), free-breathing dynamic contrast-enhanced (DCE) sequence), mpMRI has become a promising imaging technology. In addition, given the advantages of non-radiation, non-invasiveness, and excellent soft tissue contrast, mpMRI may be more suitable for neoadjuvant therapy patients who require multiple evaluations.

Patients with gastric cancer confirmed by endoscopic biopsy will be prospectively included in this study. Patients undergo both mpMRI and DECT at baseline to stage the primary tumor, regional lymph nodes, and to rule out distant sites of disease. The interval between mpMRI and DECT examinations should not exceed 7 days. All patients will be treated according to standard practice in our institution. Patients receiving neoadjuvant chemotherapy will undergo mpMRI and DECT scan again for restaging. The postoperative pathology results of these two examination methods were prospectively collected, and their efficacy was calculated according to the reference standard. After completion of study intervention, patients are followed up periodically.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients with preoperative pathologically confirmed GC by endoscopy and preoperative imaging data (DECT/mpMRI) were included.
  • No contraindications for CT/MRI examination
  • Written informed consent

排除标准

  • Patients with a history of previous therapy.
  • Patients with recurrent gastric cancer
  • Patients with a history of severe allergy to contrast agents
  • Patients with imaging artefacts affect the evaluation

结局指标

主要结局

Diagnostic performance of DECT and mpMRI in tumor staging assessment

时间窗: 2 years

Accuracy for both imaging techniques in the prediction of tumor staging.

Diagnostic performance of DECT and mpMRI in tumor restaging assessment

时间窗: 2 years

Accuracy for both imaging techniques in the prediction of tumor restaging.

次要结局

  • Overall survival (OS)(5 years)
  • Predictive value of DECT and mpMRI after the neoadjuvant treatment for pathologic response(4 years)
  • The kappa value(2 years)
  • Contrast-to-noise Ratio (CNR)(6 months)
  • Disease free survival (DFS)(4 years)
  • The signal-to-noise Ratio (SNR)(6 months)
  • Likert scales 1-5(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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