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Not yet recruiting NCT07252882

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

No phase Interventional Magnetic Resonance Imaging (MRI) Urologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upper urinary tract magnetic resonance imaging.
Who it may be relevant to
Registry conditions: Magnetic Resonance Imaging (MRI), Urologic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Upper urinary tract invasive cancer magnetic resonance imaging diagnosis

Detailed description

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.

Interventions

  • Radiation 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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 11 centers
  • 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
  • … and 3 more centers

Identifiers

NCT: NCT07252882 · RC31/23/0389

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗