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临床试验/NCT07252882
NCT07252882尚未招募不适用

Interest of Magnetic Resonance Imaging in the Diagnosis of Upper Urinary Tract Invasive Tumours

University Hospital, Toulouse11 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
178
试验地点
11
主要终点
Diagnostic validity (composite criteria sensitivity and specifcity) of a predefined magnetic resonance imaging sequence in the diagnosis of upper urinary tract invasive tumour

研究概览

简要总结

Upper urinary tract invasive cancer magnetic resonance imaging diagnosis

详细描述

Urothelial tumours are the 6th most common cause of cancer in developed countries and occur throughout the urinary tract (urethra, bladder, ureter and pelvic cavities). Upper urinary tract tumours account for 5-10% of urothelial carcinomas. Nearly 60% of patients with upper urinary tract tumours are diagnosed as invasive (≥ T2). 90% of computed tomography lesions are tumour lesions. Currently, the diagnosis of upper urinary tract tumours is based on computed tomography with injection of nephrotoxic iodinated contrast medium (uro-computed tomography) and biopsies taken during ureteroscopy under general anaesthesia. Invasive tumours have a poor prognosis and patients with infiltrating tumours may benefit from neoadjuvant chemotherapy prior to nephroureterectomy (which may impair renal function). Uro-computed tomography cannot differentiate between invasive and non-invasive tumours and biopsies taken in the operating theatre during ureteroscopy under general anaesthesia are unreliable for staging and frequently underestimate the disease. The diagnosis of infiltrating tumours is most often made on nephro-ureterectomy specimens, making neoadjuvant treatment impossible. Recently, functional magnetic resonance imaging sequences (diffusion weighted imaging, apparent diffusion coefficient) highlighted the biophysical properties of the tissues such as cellular organisation, density and microcirculation and have thus made it possible to differentiate benign from malignant lesions by identifying the level of tissue involvement. Magnetic resonance imaging has become a real tool in the diagnosis of bladder tumours and can differentiate between infiltrating and non-infiltrating lesions.

The aim of this study is to make magnetic resonance imaging for each patient and compare results to pathological analysis (nephro-ureterectomy pathologic analysis or biopsy with 3 months Uro-computed tomography) to evaluate magnetic resonance imaging diagnosis capability for invasive tumour.

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
否

入选标准

  • •Patient over 18 years of age with a suspected upper urinary tract tumour based on the presence of a suspicious lesion on a uro-computed tomography scan
  • •Have given free, informed and signed consent
  • •Be affiliated to a social security scheme

排除标准

  • •Renal failure not allowing the injection of iodinated contrast media (Glomerular filtration rate <30mL/min)
  • •Subject under legal protection (guardianship or curatorship)
  • •Pregnant or breastfeeding woman
  • •Person participating in another research study or having participated in a protocol with an exclusion period still in progress at inclusion
  • •Contraindication to magnetic resonance imaging (patient with non-magnetic resonance imaging compatible equipment, claustrophobia preventing magnetic resonance imaging)
  • •Acide gadoteric hypersensibility

研究组 & 干预措施

Patients with upper urinary tract tumour

Experimental

Patients with upper urinary tract tumour and will have upper urinary tract magnetic resonance imaging

干预措施: Upper urinary tract magnetic resonance imaging (Radiation)

结局指标

主要结局

Diagnostic validity (composite criteria sensitivity and specifcity) of a predefined magnetic resonance imaging sequence in the diagnosis of upper urinary tract invasive tumour

时间窗: 3 months

Diagnostic validity (sensitivity and specifcity) of a predefined magnetic resonance imaging sequence in the diagnosis of upper urinary tract invasive tumour (taking as reference the pathological analysis \[gold standard\] or biopsy with 3 months Uro-CT).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

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