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临床试验/NCT03347630
NCT03347630Unknown不适用

Prospective Evaluation of MRI in Pre-operative Staging of Esophagus Cancers

Dromain Clarisse2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
diagnostic performance for staging

研究概览

简要总结

The role of MRI in the management of esophageal cancer remains unclear and poorly studied. Recent technical advances suggest that MRI may become a powerful technique for the initial assessment of esophageal cancer, but also for the evaluation of response to neo-adjuvant treatment before surgery.

This imaging study will be performed prospectively and consecutively in 60 patients included over a 18-month period in patients wîth newly diagnosed esophageal cancer.

The aim of this study is to assess the accuracy of MRI to visualize esophageal tumors, to assess tumor burden and potential contact with adjacent structures as well as associated lymph nodes. If chemotherapy or radio-chemotherapy treatment is indicated before surgery, we will also evaluate whether MRI helps us to better evaluate the response to this treatment in comparison to PET-scan or echo. endoscopy which are the examinations currently performed to evaluate the effectiveness of these treatments.

The images of the MRI exams will be interpreted by 1 expert radiologist with no knowledge of the other imaging modalities and transmitted to the doctors in charge for possible consideration for the treatment.

Patients will then be followed for one year according to clinical management standards to study the data on treatment complications and cancer progression at one year.

The main risk is the administration of a gadolinium chelate-based MRI contrast product used routinely. There is also a risk that the results of the MRI may influence the treatment initially planned for example by canceling a surgical procedure.

详细描述

The study will be proppsed consecutively to all patients with a histologically proven diagnosis of esophageal cancer.

An MRI examination including morphological sequences (without and with injection of a gadolinium chelate) functional and dynamic will be carried out in all the patients for initial staging in addition to other diagnostic procedure performed in clinical routine in this indication that are the endo-ultrasonography, CT and PET scanner.

In patients for whom neo-adjuvant treatment with chemotherapy or radio-chemotherapy will be decided and started, a second MRI will be performed 4 to 6 weeks after the end of the neo-adjuvant treatment.

The images of the MR exams will be interpreted by 1 expert radiologist blinded from data of other imaging modalities and transmitted to the doctors in charge of the patient for possible consideration for the treatment.

Patients will then be followed for one year according to regular recommandation to assess mortality / morbidity and PFS at 1 year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Any pathologically proven oesophagus cancer

排除标准

  • MRI contraindication
  • Pregnant women
  • cervical esophagus cancer

研究组 & 干预措施

oesophagus cancer MRI

Other

Diagnostic test

干预措施: MRI (Diagnostic Test)

结局指标

主要结局

diagnostic performance for staging

时间窗: 18 months

TNM staging

次要结局

  • Diagnostic performance for staging(18 months)
  • Diagnostic performance to assess tumor response(18 months)
  • Prognostic biomarker(18 months)

研究者

发起方
Dromain Clarisse
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dromain Clarisse

MD, phD

University of Lausanne Hospitals

研究点 (2)

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