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临床试验/NCT04913896
NCT04913896Unknown不适用

Clinical Study of CT and MRI in Prediction of Response in Patients With Gastric Cancer Following Neoadjuvant Chemotherapy and/or Immunotherapy

The First Hospital of Jilin University0 个研究点目标入组 200 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
200
主要终点
Predictive value of CT and MRI after the neoadjuvant treatment for developing a pCR at surgery

研究概览

简要总结

This is a prospective and observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with advanced gastric cancer (AGC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) and CT data. This study will help the surgeons to better formulate treatment regimens for gastric cancer in the clinical practice.

详细描述

With the gradual development of neoadjuvant immunotherapy and/or chemotherapy in the clinic, the pCR has become more and more accessible in the AGC. Preoperative accurate prediction of pCR is of great clinical significance. The contrast-enhanced CT and 3.0T MRI were carried out in patients within 1 week prior to commencing neoadjuvant treatment, as well as 1 week within surgery after the completion of neoadjuvant treatment, respectively. Based on the information extracted from the CT/MRI, the clinical completed response (cCR) and the clinical T staging were compared with pCR, pathologic T staging. The pathologic results were considered as the golden standard. With the ROC curve analysis, the diagnosis coincidence rate, sensitivity and specificity were assessed. The AI prediction model would be constructed and trained. The depth convolution neural network based on contrast-enhanced CT and multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and histopathologic response, could further help to improve the prediction of response of gastric cancer treated with systematic therapy. The abdominal contrast-enhanced CT will focus on parameters: Local T Staging, nodal status, diameter, according to RECIST 1.1. MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will focus on parameters: DWI & ADC value (preferably on a single camera with reproducible ADC value), Local T Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.

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

入选标准

  • Age 18 Years to 80 Years
  • Consecutive patients with preoperative pathologically confirmed AGC by endoscopy and preoperative imaging data (CT/MRI) were included.
  • Clinical staging Ⅱ-Ⅲ according to the UICC/AJCC 8th guideline for gastric cancer without distant metastasis.
  • Suitable for pre-operative chemotherapy, immunotherapy and surgical resection
  • No contraindications for CT/MRI examination.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-
  • The patients participate in this study with informed consent.

排除标准

  • Patients with a history of previous chemotherapy or immunotherapy.
  • The patients couldn't perform MSCT or MR scanning or artefacts affect the evaluation.
  • The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy.
  • The patients refuse to participate in the project.
  • Pregnancy, lactation or inadequate contraception
  • Pacemaker or implanted defibrillator
  • Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study.
  • Other situations considered by investigators, which not meet the inclusion criteria.

研究组 & 干预措施

Single Group Assignment

Patients with AGC who underwent neoadjuvant immunotherapy and/or chemotherapy would recieve MRI and CT examination before and after 3 cycles treatment.

干预措施: PD-1 inhibitor (Drug)

结局指标

主要结局

Predictive value of CT and MRI after the neoadjuvant treatment for developing a pCR at surgery

时间窗: up to 2 year

Predictive value of CT and MRI after the neoadjuvant treatment for developing a pathologic complete response at surgery (Grade 0 - no viable cancer cells seen in the resection specimen).

次要结局

  • Predictive value of CT and MRI after the neoadjuvant treatment for pathologic T staging(up to 2 year)
  • Prediction model based on CT and MRI of response in AGC(up to 2 year)
  • Predictive value of CT and MRI after the neoadjuvant treatment for pathologic response according to the Tumor Regression Grading (TRG)(up to 2 year)

研究者

申办方类型
Other
责任方
Sponsor

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