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Набор скоро начнётся NCT07252882

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

Без фазы С лечением Magnetic Resonance Imaging (MRI) Urologic Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Upper urinary tract magnetic resonance imaging.
Кому может быть актуально
Состояния в реестре: Magnetic Resonance Imaging (MRI), Urologic Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Upper urinary tract invasive cancer magnetic resonance imaging diagnosis

Подробное описание

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.

Вмешательства

  • Лучевая терапия Upper urinary tract magnetic resonance imaging
    Patients with a suspected malignant tumour of the upper urinary excretory tract based on the presence of a suspicious lesion on a uro-computed tomography scan will have a diagnostic magnetic resonance imaging of the urinary tract with Gadolinium-based contrast agents

Первичные конечные точки

  • Diagnostic validity (composite criteria sensitivity and specifcity) of a predefined magnetic resonance imaging sequence in the diagnosis of upper urinary tract invasive tumour [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 11 центров
  • Hôpital Pellegrin — Bordeaux
  • Hôpital Claude Huriez — Lille
  • Institut Paoli Calmettes — Marseille
  • Clinique Beau Soleil — Montpellier
  • Hôpital Lapeyronie — Montpellier
  • Hôpital Saint-Louis — Paris
  • Hôpital de la Pitié Salpêtrière — Paris
  • Hôpital Européen Georges Pompidou — Paris
  • … и ещё 3 центра

Идентификаторы

NCT: NCT07252882 · RC31/23/0389

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗