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

Upper urinary tract invasive cancer magnetic resonance imaging diagnosis

Study Overview

• Status: Not yet recruiting
• Conditions: Urologic Cancer; Magnetic Resonance Imaging (MRI)
• Intervention / Treatment: Radiation: Upper urinary tract magnetic resonance imaging

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.

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas PRUDHOMME, MD; Phone Number: 33 0561322748; Email: prudhomme.t@chu-toulouse.fr

Study Locations

• France
  • France
    • Bordeaux, France, France, 33000
      • Hôpital Pellegrin
      • Contact: Eva JAMBON, MD; Phone Number: 33 0557820846; Email: eva.jambon@chu-bordeaux.fr
      • Principal Investigator: Eva JAMBON, MD
    • Lille, France, France, 59037
      • Hopital Claude Huriez
      • Contact: Gautier MARCQ, MD; Phone Number: 33 0320444202; Email: gautier.marq@chu-lille.fr
      • Principal Investigator: Gautier MARCQ, MD, PhD
    • Marseille, France, France, 13009
      • Institut Paoli Calmettes
      • Contact: Géraldine PIGNOT LEQUEUX, MD; Phone Number: 33 0617174950; Email: pignotg@ipc.unicancer.fr
      • Principal Investigator: Géraldine PIGNOT LEQUEUX, MD
    • Montpellier, France, France, 34070
      • Clinique Beau Soleil
      • Contact: Grégoire POINAS, MD; Phone Number: 33 0467456904; Email: g.poinas@languedoc-mutualite.fr
      • Principal Investigator: Grégoire POINAS, MD
    • Montpellier, France, France, 34295
      • Hopital Lapeyronie
      • Contact: Cécile MANCEAU, MD; Phone Number: 33 0677283524; Email: cecile.manceau@chu-montpellier.fr
      • Principal Investigator: Cécile MANCEAU, MD
    • Paris, France, France, 75010
      • Hopital Saint-Louis
      • Contact: Alexandra MASSON-LECOMTE, MD, PhD; Phone Number: 33 0142499615; Email: alexandra.massonlecomte@aphp.fr
      • Principal Investigator: Alexandra MASSON-LECOMTE, MD, PhD
    • Paris, France, France, 75013
      • Hôpital de la Pitiê Salpêtriêre
      • Contact: Thomas SEISEN, MD; Phone Number: 33 0673265693; Email: thomas.seisen@aphp.fr
      • Principal Investigator: Thomas SEISEN, Md
    • Paris, France, France, 75015
      • Hopital Europeen Georges Pompidou
      • Contact: François AUDENET, MD, PhD; Phone Number: 33 0000; Email: francois.audenet@aphp.fr
      • Principal Investigator: François AUDENET, MD, PhD
    • Quint-Fonsegrives, France, France, 31130
      • Clinique La Croix Du Sud
      • Contact: Jacques ASSOUN, MD; Phone Number: 33 0615203690; Email: jacques.assoun@wanadoo.fr
      • Principal Investigator: Jacques ASSOUN, MD
    • Toulouse, France, France, 31059
      • CHU de Toulouse
      • Contact: Thomas PRUDHOMME, MD; Phone Number: 33 0561322748; Email: prudhomme.t@chu-toulouse.fr
      • Principal Investigator: Thomas PRUDHOMME, MD
    • Toulouse, France, France, 31076
      • Clinique Pasteur
      • Contact: Mathieu ROUMIGUIE, MD, PhD; Phone Number: 33 0561323229; Email: roumiguie.m@chu-toulouse.fr
      • Principal Investigator: Mathieu ROUMIGUIE, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with upper urinary tract tumour; Patients with upper urinary tract tumour and will have upper urinary tract magnetic resonance imaging	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic validity (composite criteria sensitivity and specifcity) of a predefined magnetic resonance imaging sequence in the diagnosis of upper urinary tract invasive tumour	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).	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 20, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Upper urinary tract magnetic resonance imaging
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms
• Other Study ID Numbers: RC31/23/0389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No