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NCT Number: NCT07252882

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

Upper urinary tract invasive cancer magnetic resonance imaging diagnosis

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pellegrin, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upper urinary tract magnetic resonance imaging

Radiation

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 outcomes

  1. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas PRUDHOMME, MD

CONTACT

[email protected]

0561322748 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: UUTICaD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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