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临床试验/NCT03635619
NCT03635619Unknown不适用

3 T MRI in the Preoperative TN Staging and Prediction of Response to Neoadjuvant Therapy in Patients With Esophageal Cancer

Henan Cancer Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年9月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
MRI TN staging in Esophageal Cancer

研究概览

简要总结

It is very significant that assessing TN staging in esophageal cancer patients before surgery, furthermore, determining the optimize surgical strategy, predict the the efficacy of radiotherapy for patients who were not chosen to be surgeried, and define the range of lymph node for radiotherapy. It has been reported that the application of MRI in metastasis of lymph node of other cancer, but not in metastasis lymph node with esophageal cancer. Only a few studies focused on T staging using conventional MRI in esophageal cancer, however, relatively new sequences in the chest deserve widely used. To develop a pre-treatment evaluation methods for TN staging in patient with esophageal cancer by utilization of the new imaging methods (T2-TSE-BLADE, T2 maps, StarVIBE). By analysising the relationship between TN staging and imaging features to find the imaging characteristics for TN staging, and to find the indicators of magnetic resonance imaging new technology and reference values for facilitate pre-treatment diagnosis of lymphnode metastasis, optimize surgical strategy, predict the the efficacy of adjunctive therapy, and OS and define the range of lymph node for radiotherapy, as making personal treatment planning for esophageal cancer.

详细描述

To explore the value of 3 T MRI using multiple sequences, including T2-TSE-BLADE, T2 maps and StarVIBE, in evaluating the preoperative TN staging and prediction of response to neoadjuvant therapy and OS in patients with esophageal cancer.

Patients with endoscopically biopsy-proven EC were prospectively enrolled for imaging on a 3 T scanner. The MRI protocol included T2-TSE-BLADE, T2 maps and StarVIBE sequences, and so on. Patients received treatment according to NCCN guideline. Readers assigned a TN stage on MRI, and post-operative pathologic confirmation was considered the gold standard. Inter-reader agreement, the diagnostic accuracy of TN staging on MRI were analyzed and compared to post-operative pathologic TN staging. MRI features were analyzed to find the correlation between pretreatment MRI features and response or OS. The study will includ 400 patients. Inter-reader agreements of TN staging were analyzed excellent for MRI. Diagnostic accuracy of MRI will be calculated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients with preoperative pathologically con-firmed EC by endoscopy and preoperative imaging data (esophagography\CT\EUS\MRI) were included.
  • No contraindications for MRI examination.
  • The patients participate in this study with informed consent.

排除标准

  • The patients couldn't performed MR scanning or artefacts affect the evaluation.
  • ThePatients are extremely anxious and uncooperative about surgery or neoadjuvant therapy.
  • PatientsThe patients refuse to participate in the project.

结局指标

主要结局

MRI TN staging in Esophageal Cancer

时间窗: Sep 1, 2018-Dec 31, 2019

To explore the value of 3 T MRI using multiple sequences in evaluating the preoperative TN staging of esophageal cancer treated with surgery, with pathologic confirmation

次要结局

  • MRI prediction of prognosis in esophageal cancer(Sep 1, 2018-Dec 31, 2020)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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