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临床试验/NCT03543215
NCT03543215招募中不适用

Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer?

Imperial College London1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年7月13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
500
试验地点
1
主要终点
To assess the value of MRI features in predicting prognosis in patients with endometrial cancer using progression free survival (PFS) and overall survival (OS) as end points

研究概览

简要总结

Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer

This study will examine the MRI features of women with confirmed endometrial cancer to see if textural features can prognosticate patients.

详细描述

Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer

Background:

Endometrial cancer is the commonest gynaecological cancer in the United Kingdom. MR Imaging is used to provide pre-treatment local staging in Endometrial Cancer based on the FIGO staging system. This MRI stage is used by clinicians, in combination with pre-operative histology and clinical assessment of the patient, to counsel patients about their prognosis.

Currently the information obtained from the MRI study is largely anatomical and concerns the extent of local tumour spread at the time of diagnosis. Each stage under the FIGO system is associated with a prognosis based on data from the literature. Important prognostic indicators include the depth of tumour invasion in the uterine muscle (myometrium), invasion of the cervical stroma by tumour, spread to lymph node tissues and the histological sub-type of tumour present.

However, with ever improving MRI technology there are now newer sequences employed as part of the staging study which may potentially yield more information. In other cancer types, e.g. prostate, breast and liver, textural analysis of the tumour on pre-treatment imaging (CT/PET-CT/MRI) is being analysed to try and identify features which could be used as prognostic markers for patient outcome.

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
Female
接受健康志愿者

入选标准

  • All women presenting with a confirmed diagnosis of endometrial cancer
  • Reviewed at the Specialist Gynaecology Oncology MDT
  • Have MR Imaging and Hysterectomy specimens available for review.
  • Exclusion criteria:
  • Anyone lacking capacity.
  • <18years old.
  • Pregnant.
  • No MR Imaging available for review -- No pathology specimen available for review

排除标准

  • 未提供

结局指标

主要结局

To assess the value of MRI features in predicting prognosis in patients with endometrial cancer using progression free survival (PFS) and overall survival (OS) as end points

时间窗: 8 years (3 year data collection and 5 year follow up).

Assess features of pelvic MRIs (including (i) tumour image intensity, (II) shape, (III) texture and (IV) multiscale wavelet) and create a mathematical algorithm to predict prognostic outcome (5 year survival).

次要结局

  • Assess the correlation between imaging features and histopathological features.(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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